Organon Teknika Corp.
Organon Teknika Corp. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2000.
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.