Wako Chemicals USA, Inc.
FDA 510(k) medical device clearances.
Top product codes for Wako Chemicals USA, Inc.
Recent clearances by Wako Chemicals USA, Inc.
1–100 of 124- K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
- K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
- K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
- K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
- K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
- K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
- K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
- DEN050002 — LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
- K042551 — MULTI-CHEM CALIBRATOR A
- K042549 — MULTI CHEM CAL B
- K042550 — MULTI-LIPID CALIBRATOR
- K040918 — WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
- K033860 — AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
- K040226 — WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
- K024280 — WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
- K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
- K024281 — WAKO L-TYPE GLUCOSE 2
- K030065 — WAKO NEFA LINEARITY SET
- K020972 — WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
- K010332 — WAKO IMMUNOASSAY CALIBRATOR SET
- K010325 — WAKO AUTOKIT C4
- K010326 — WAKO AUTOKIT C3
- K010334 — WAKO LIPID CALIBRATOR
- K003342 — WAKO CRP-UL, CRP-UL CALIBRATOR SET
- K001929 — WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
- K001931 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
- K001933 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
- K001934 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
- K001919 — WAKO AUTOKIT LP(A)/DADE DEMENSION
- K001920 — WAKO AUTOKIT LP(A)/ RA,500/1000,
- K001921 — WAKO AUTOKIT LP(A)/EXPRESS 550
- K001004 — WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
- K001005 — WAKO HDL-C/LDL-C CALIBRATOR
- K001002 — WAKO LIPASE CALIBRATOR
- K993925 — WAKO L-TYPE UN TEST
- K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993924 — WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
- K993468 — WAKO L-TYPE GOT TEST
- K993162 — WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
- K993219 — WAKO BILIRUBIN CALIBRATOR
- K993466 — WAKO L-TYPE TRIGLYCERIDE TEST
- K993469 — WAKO L-TYPE UA F TEST
- K981446 — WAKO AUTOKIT LP(A)
- K984122 — WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
- K984119 — WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
- K984184 — WAKO L-TYPE AMYLASE
- K982271 — WAKO DIRECT LDL-C
- K973055 — WAKO CH50 LINEARITY SET
- K973072 — WAKO NEFA LINEARITY SET
- K970986 — WAKO DIRECT BILIRUBIN V
- K970985 — WAKO TOTAL BILIRUBIN V
- K963847 — WAKO DIRECT HDL-C
- K960874 — COMPLEMENT CONTROL
- K955156 — WAKO AUTOKIT CRP NEW
- K954657 — WAKO AUTOKIT APO B
- K954145 — WAKO AUTOKIT CH50
- K950172 — WAKO AUTOKIT GLUCOSE
- K952615 — WAKO AUTOKIT APO A1
- K944664 — WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
- K923070 — WAKO IGG-HA
- K922151 — WAKO AUTOKIT RF
- K921249 — WAKO AUTOKIT LIPASE-COLOR
- K920531 — WAKO AUTOKIT MICRO TP
- K912024 — AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
- K902216 — WAKO(TM) MICRO-ALBUMIN
- K901544 — WAKO(TM) AUTOKIT URIC ACID
- K895984 — WAKO(TM) AUTOKIT GAMMA-GT
- K895598 — WAKO(TM) AUTOKIT CRP
- K883059 — WAKO(TM) AUTOKIT AMYLASE
- K882374 — WAKO(TM) CRP
- K880784 — WAKO(TM) IGG-HA DIRECT
- K880803 — WAKO(TM) IGA-HA DIRECT
- K880828 — WAKO(TM) IGM-HA DIRECT
- K880312 — WAKO(TM) AUTOKIT TOTAL PROTEIN
- K880313 — WAKO(TM) AUTOKIT ALBUMIN
- K880731 — WAKO AUTOKIT URIC ACID
- K880311 — WAKO(TM) AUTOKIT CHOLESTEROL
- K873409 — WAKO(TM) PRETEST 6A
- K875176 — WAKO(TM) UIBC
- K873366 — WAKO(TM) PRETEST 5A
- K874640 — WAKO(TM) AUTOKIT LIPASE
- K871755 — PROTEIN STANDARD CALIBRATOR
- K874263 — WAKO(TM) FE C
- K873201 — WAKO(TM) AUTOKIT CK-NAC
- K873333 — WAKO(TM) AUTOKIT ALP
- K873334 — WAKO(TM) AUTOKIT CALCIUM
- K873335 — WAKO(TM) AUTOKIT UREA N
- K871759 — G-GT STANDARD CALIBRATOR
- K873553 — WAKO(TM) PRETEST 8A
- K872051 — CALCIUM CALIBRATOR
- K863920 — WAKO(TM) ZN TEST
- K872918 — GIT SERUM-FREE MEDIUM FOR CELL CULTURE
- K872263 — TOTAL BILIRUBIN STANDARD CALIBRATOR
- K870095 — BILIRUBIN TESTER
- K871756 — CREATININE STANDARD SOLUTION CALIBRATOR
- K871758 — GLUCOSE STANDARD SOLUTION CALIBRATOR
- K871762 — MAGNESIUM STANDARD SOLUTION CALIBRATOR
- K871763 — NEFA STANDARD SOLUTION CALIBRATOR
- K871764 — INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.