Organon Teknika Corp. - FDA 510(k) Cleared Devices
130
Total
129
Cleared
0
Denied
130 devices
Cleared
Jul 22, 1996
MB/BACT MYCROBACTERIA DETECTION SYSTEM
Microbiology
300d
Cleared
Nov 14, 1995
AURAFLEX TESTOSTERONE CALIBRATOR PACK
Chemistry
218d
Cleared
Oct 06, 1995
MDA SIMPLASTIN LS
Hematology
121d
Cleared
Aug 25, 1995
AURAFLEX TG-AB AND TPO-AB
Immunology
155d
Cleared
Aug 25, 1995
AURAFLEX TPO-AB
Immunology
86d
Cleared
Jun 20, 1995
AURAFLEX B2-MICROGLOBULIN
Immunology
263d
Cleared
May 08, 1995
AURAFLEX PROGESTERONE 150TEST PACK
Chemistry
31d
Cleared
May 02, 1995
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
Chemistry
22d
Cleared
Apr 03, 1995
AURAFLEX(R) ESTRADIOL
Chemistry
104d
Cleared
Mar 21, 1995
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
Chemistry
179d
Cleared
Mar 20, 1995
AURAFLEX HCG
Chemistry
139d
Cleared
Mar 03, 1995
MICROPLATE PROCESSOR 3000
Chemistry
134d
Cleared
Feb 22, 1995
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
Chemistry
152d
Cleared
Feb 17, 1995
BACT/ALERT FAN CULTURE BOTTLE
Microbiology
151d
Cleared
Dec 09, 1994
IMX T3 ASSAY
Chemistry
71d
Cleared
Sep 20, 1994
AURATEK FDP
Hematology
48d
Cleared
Aug 30, 1994
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
Microbiology
273d
Cleared
Aug 26, 1994
AURAFLEX SYSTEMS
Chemistry
95d
Cleared
Jun 02, 1994
PREDICTOR HOME PREGNANCY TEST
Chemistry
108d
Cleared
Apr 21, 1994
FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
Hematology
569d
Cleared
Apr 21, 1994
OT IGG SORBENT
Microbiology
230d
Cleared
Feb 09, 1994
BACT/ALERT 120
Microbiology
138d
Cleared
Feb 07, 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
Microbiology
179d
Cleared
Jan 27, 1994
MDA PROTEIN ASSAY
Hematology
447d
Cleared
Apr 20, 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
Hematology
61d
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