Em Diagnostic Systems, Inc.
FDA 510(k) medical device clearances.
Top product codes for Em Diagnostic Systems, Inc.
Recent clearances by Em Diagnostic Systems, Inc.
1–100 of 288- K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST
- K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST
- K935178 — EMDS PHOSPHOROUS (PHOS) TEST
- K935179 — EMDS ALBUMIN (ALB) TEST
- K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410
- K935174 — TOTAL PROTEIN TEST (TPRO)
- K935175 — LACTATE DEHYDROGENASE (LD)
- K935176 — IRON TEST
- K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
- K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST
- K935183 — EMDS MAGNESIUM (MG) TEST
- K932158 — CALCIUM TEST ITEM NUMBER 65409
- K932162 — URIC ACID TEST ITEM NUMBER 65422
- K932159 — SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
- K932161 — UREA NITROGEN TEST ITEM NUMBER 65408
- K931891 — TRIGLYCERIDES
- K931582 — ETHYLIDENE AMYL
- K931583 — SILYL AMYL
- K931887 — BICARBONATE
- K931888 — TOTAL BILIRUBIN
- K931889 — CREATINE KINASE TEST
- K931890 — GLUCOSE-HK TEST
- K932160 — SYSTEMATE CREATININE TEST ITEM NUMBER 65413
- K930166 — IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
- K925101 — SYSTEMATE PLUS CALIBRATOR
- K924703 — LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
- K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION
- K924508 — CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
- K924710 — TRIGLYCERIDES
- K925002 — UREA NITROGEN TEST
- K923959 — ALBUMIN TEST
- K924711 — BICARBONATE
- K924572 — EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
- K924574 — EMDS ALKALINE PHOSPHATASE (ALP) TEST
- K924573 — SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
- K923733 — CHOLESTEROL TEST
- K924599 — CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
- K924470 — TWO PART INORGANIC PHOSPHORUS TEST
- K924704 — CREATINE KINASE (CK) TEST ITEM #65411
- K922947 — GAMMA GULTAMYL TRANSFERASE TEST
- K923257 — EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
- K923764 — SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
- K923765 — SYSTEMATE URICACID TEST, TECHNICON RA 1000
- K922856 — SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
- K922857 — SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
- K922953 — SYSTEMATE CALCIUM TEST TECHNICON RA 1000
- K923083 — TOTAL BILIRUBIN CATALOG NO. 65407
- K923203 — SYSTEMATE CREATININE TEST
- K923267 — SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
- K923677 — AMYLASE TEST
- K920583 — ABBOTT QUICKSTART AMYLASE, #5AXX
- K915732 — ABBOTT QUICKSTART TIGLYCERIDES REAGENT
- K914463 — ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
- K914903 — QUICKSTART UREA NITROGEN
- K913565 — ABBOTT QUICKSTART CHOLESTEROL TEST
- K914361 — CREATINE KINASE MB TEST ITEM NUMBER 5A46
- K913921 — ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
- K914018 — ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
- K914464 — ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
- K913764 — ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
- K912807 — ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
- K913466 — ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
- K914261 — ABBOTT QUICKSTART LD-1,#5A30
- K913307 — ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
- K914262 — ABBOTT QUICKSTART LDH,#5A31
- K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
- K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
- K914068 — ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
- K913706 — ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
- K913920 — ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
- K913846 — ABBOTT QUICKSTART ALANINE AMINOTRANSFER
- K913922 — ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
- K913707 — ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
- K912806 — ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
- K912809 — ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
- K912808 — ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
- K912810 — ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
- K913024 — ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
- K905658 — SYSTEMATE CREATININE (EPOS APPLICATION) #65413
- K910639 — SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
- K910640 — SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
- K910638 — SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
- K905477 — OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
- K905661 — SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
- K905660 — SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
- K905659 — SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
- K905662 — SYSTEMATE GGT (EPOS APPLICATION) #65414
- K903409 — SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
- K903198 — ALANINE AMINOTRANSFERASE TEST
- K903696 — OLYMPUS INORGANIC PHOSPHORUS
- K903334 — UREA NITROGEN TEST
- K903197 — ASPARTATE AMINOTRANSFERASE TEST
- K903332 — SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
- K903333 — CREATINE KINASE TEST (CK) ITEM NUMBER 65411
- K903335 — SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
- K902483 — CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
- K902123 — SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
- K897174 — OLYMPUS(TM) TOTAL BILIRUBIN
- K901807 — OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
- K901083 — EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
Data sourced from openFDA. This site is unofficial and independent of the FDA.