Organon Teknika Corp. - FDA 510(k) Cleared Devices
130
Total
129
Cleared
0
Denied
130 devices
Cleared
Jun 28, 1988
NEPHROSS I.Q. MODERATO
Gastroenterology & Urology
33d
Cleared
Jun 28, 1988
BIO*NEPHROSS I.Q. ANDANTE
Gastroenterology & Urology
22d
Cleared
May 27, 1988
PREGNOSPIA II
Chemistry
52d
Cleared
May 18, 1988
COAG-A-MATE(R) XM
Hematology
54d
Cleared
May 02, 1988
VERIFY(R) REFERENCE PLASMA
Hematology
33d
Cleared
Mar 15, 1988
HCG-NOSTICK
Chemistry
49d
Cleared
Feb 09, 1988
FIBRINOSTICON
Hematology
29d
Cleared
Jan 29, 1988
NEPHROSS I.Q. ANDANTE
Gastroenterology & Urology
86d
Cleared
Jan 27, 1988
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
Gastroenterology & Urology
79d
Cleared
Nov 20, 1987
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
Microbiology
31d
Cleared
Oct 02, 1987
CIPROFLOXACIN 5 MCG SUSCEPTIBILITY DISK
Microbiology
17d
Cleared
May 15, 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
Microbiology
16d
Cleared
Mar 17, 1987
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
Microbiology
97d
Cleared
Mar 17, 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
Microbiology
14d
Cleared
Mar 17, 1987
COAG-A-MATE(R) XC
Hematology
7d
Cleared
Jan 14, 1987
ERYPUR B
General Hospital
49d
Cleared
Dec 04, 1986
SIMPLASTIN EXCEL
Hematology
35d
Cleared
Sep 11, 1986
TOXONOSTIKA IGM MICROELISA SYSTEM
Microbiology
94d
Cleared
Sep 08, 1986
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
Microbiology
91d
Cleared
Jun 26, 1986
FAST FORMALERT
Gastroenterology & Urology
304d
Cleared
May 02, 1986
POSID SAMPLER
Chemistry
80d
Cleared
Apr 11, 1986
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
Microbiology
32d
Cleared
Mar 06, 1986
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
Microbiology
59d
Cleared
Dec 16, 1985
HD-SECURA HEMADIALYSIS MACHINE
Gastroenterology & Urology
48d
Cleared
Nov 08, 1985
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
Gastroenterology & Urology
32d
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