Organon Teknika Corp.
FDA 510(k) medical device clearances.
Top product codes for Organon Teknika Corp.
Recent clearances by Organon Teknika Corp.
1–100 of 130- K003104 — BACT/ALERT CSR
- K000492 — MDA D-DIMER
- K000378 — BACT/ALERT MB CULTURE BOTTLE
- K994343 — BACT/ALERT SV
- K993423 — BACT/ALERT SA
- K993421 — BACT/ALERT SN
- K993576 — BACT/ALERT MP PROCESS BOTTLE
- K992432 — BACT/ALERT FN
- K983762 — NUCLISENS CMV PP67
- K992400 — BACTALERT FA
- K992401 — BACT/ALERT PF
- K992596 — TOF-WATCH S
- K992598 — TOF-WATCH SX
- K991101 — COAG-A-MATE MAX
- K983772 — MB/BACT BLOOD CULTURE BOTTLE
- K982263 — MB/BACT BLOOD CULTURE BOTTLE
- K981736 — BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
- K974776 — MDA D-DIMER
- K974566 — MDA SIMPLASTIN HTF
- K972698 — TOF-WATCH
- K973325 — BACT/ALERT FAN CULTURE BOTTLES
- K973305 — BACT/ALERT CULTURE BOTTLES
- K964934 — THROMBONOSTIKA F1.2
- K965076 — MDA HEPARIN ANTI-X ASSAY
- K962857 — COAG-A-MATE MTX
- K954468 — MB/BACT MYCROBACTERIA DETECTION SYSTEM
- K951685 — AURAFLEX TESTOSTERONE CALIBRATOR PACK
- K952608 — MDA SIMPLASTIN LS
- K951320 — AURAFLEX TG-AB AND TPO-AB
- K952607 — AURAFLEX TPO-AB
- K944846 — AURAFLEX B2-MICROGLOBULIN
- K951630 — AURAFLEX PROGESTERONE 150TEST PACK
- K951638 — AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
- K946199 — AURAFLEX(R) ESTRADIOL
- K944698 — AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
- K945331 — AURAFLEX HCG
- K945135 — MICROPLATE PROCESSOR 3000
- K944697 — AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
- K944594 — BACT/ALERT FAN CULTURE BOTTLE
- K944808 — IMX T3 ASSAY
- K943787 — AURATEK FDP
- K935711 — BACT/ALERT FAN AEROBIC CULTURE BOTTLE
- K942443 — AURAFLEX SYSTEMS
- K940637 — PREDICTOR HOME PREGNANCY TEST
- K924892 — FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
- K934324 — OT IGG SORBENT
- K934593 — BACT/ALERT 120
- K933939 — BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
- K925617 — MDA PROTEIN ASSAY
- K930849 — VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
- K924453 — MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
- K921396 — PLATELIN L
- K915698 — FIBRINOSTIKA TDP MICROELISA SYSTEM
- K920249 — BACT/ALERT PEDI-BACT
- K915746 — SIMPLASTIN L
- K911434 — THROMBONOSTIKA F1.2
- K912876 — FIBRINOSTIKA FBDP MICROELISA SYSTEM
- K911745 — SIMPLATE PEDIATRIC
- K910617 — NATIVE PROTHROMBIN ANTIGEN EIA
- K911393 — RUBENOSTIKA IGG MICROELISA SYSTEM
- K903505 — BACT/ALERT (TM)
- K903841 — ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
- K903567 — BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
- K900895 — COAG-A-MATE - RA4
- K900917 — COAG-A-MATE - RA4
- K900344 — CEFIXIME 5 MCG SUSCEPTIBILITY DISK
- K895392 — ANTIMICROBIAL SUSCEPTIBILITY DISK
- K890610 — VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
- K882999 — RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
- K885076 — COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
- K884695 — WASHER 500 MICROELISA SYSTEM
- K882428 — REDY 2000
- K881999 — PLATELIN(R) EXCEL L
- K882214 — SIMPLASTIN EXCEL S
- K882213 — NEPHROSS I.Q. ALLEGO
- K882215 — NEPHROSS I.Q. MODERATO
- K882339 — BIO*NEPHROSS I.Q. ANDANTE
- K881435 — PREGNOSPIA II
- K881281 — COAG-A-MATE(R) XM
- K881348 — VERIFY(R) REFERENCE PLASMA
- K880328 — HCG-NOSTICK
- K880077 — FIBRINOSTICON
- K874549 — NEPHROSS I.Q. ANDANTE
- K874607 — FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
- K874256 — AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
- K873707 — CIPROFLOXACIN 5 MCG SUSCEPTIBILITY DISK
- K871674 — TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
- K864848 — NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
- K870870 — AZTREONAM 30 MCG SUSCEPTIBILITY DISK
- K870960 — COAG-A-MATE(R) XC
- K864636 — ERYPUR B
- K864283 — SIMPLASTIN EXCEL
- K862196 — TOXONOSTIKA IGM MICROELISA SYSTEM
- K862189 — ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
- K853555 — FAST FORMALERT
- K860508 — POSID SAMPLER
- K860895 — CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
- K860031 — GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
- K854367 — HD-SECURA HEMADIALYSIS MACHINE
- K854084 — PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.