Organon Teknika Corp. - FDA 510(k) Cleared Devices
130
Total
129
Cleared
0
Denied
130 devices
Cleared
Dec 18, 1992
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
Hematology
107d
Cleared
Oct 19, 1992
PLATELIN L
Hematology
210d
Cleared
Aug 05, 1992
FIBRINOSTIKA TDP MICROELISA SYSTEM
Hematology
226d
Cleared
Apr 23, 1992
BACT/ALERT PEDI-BACT
Microbiology
93d
Cleared
Feb 12, 1992
SIMPLASTIN L
Hematology
51d
Cleared
Oct 31, 1991
THROMBONOSTIKA F1.2
Hematology
212d
Cleared
Oct 09, 1991
FIBRINOSTIKA FBDP MICROELISA SYSTEM
Hematology
100d
Cleared
Aug 09, 1991
SIMPLATE PEDIATRIC
Hematology
113d
Cleared
May 15, 1991
NATIVE PROTHROMBIN ANTIGEN EIA
Immunology
92d
Cleared
Apr 29, 1991
RUBENOSTIKA IGG MICROELISA SYSTEM
Microbiology
31d
Cleared
Mar 12, 1991
BACT/ALERT (TM)
Microbiology
221d
Cleared
Oct 22, 1990
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
Hematology
62d
Cleared
Sep 24, 1990
BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
Gastroenterology & Urology
48d
Cleared
Apr 16, 1990
COAG-A-MATE - RA4
Hematology
48d
Cleared
Apr 16, 1990
COAG-A-MATE - RA4
Hematology
48d
Cleared
Feb 05, 1990
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
Microbiology
13d
Cleared
Oct 24, 1989
ANTIMICROBIAL SUSCEPTIBILITY DISK
Microbiology
49d
Cleared
Jun 23, 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
Microbiology
136d
Cleared
Jan 31, 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
Microbiology
197d
Cleared
Dec 30, 1988
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
Hematology
22d
Cleared
Dec 13, 1988
WASHER 500 MICROELISA SYSTEM
Microbiology
34d
Cleared
Oct 25, 1988
REDY 2000
Gastroenterology & Urology
134d
Cleared
Aug 17, 1988
PLATELIN(R) EXCEL L
Hematology
97d
Cleared
Jul 01, 1988
SIMPLASTIN EXCEL S
Hematology
36d
Cleared
Jun 28, 1988
NEPHROSS I.Q. ALLEGO
Gastroenterology & Urology
33d
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