Medical Device Manufacturer · US , Mchenry , IL

Organon Teknika Corp. - FDA 510(k) Cleared Devices

130 submissions · 129 cleared · Since 1980

130

Total

129

Cleared

0

Denied

38 devices

26-38 of 38

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 13, 1988

WASHER 500 MICROELISA SYSTEM

Microbiology · 34d

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 Sep 11, 1986

TOXONOSTIKA IGM MICROELISA SYSTEM

Microbiology · 94d

Cleared Sep 08, 1986

ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM

Microbiology · 91d

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