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

FDA 510(k) Regulatory Record - Organon Teknika Corp. Microbiology ✕

38 devices

1-12 of 38

Cleared Oct 20, 2000

Microbiology · 52d

Cleared Mar 02, 2000

BACT/ALERT MB CULTURE BOTTLE

Microbiology · 24d

Cleared Feb 10, 2000

Microbiology · 49d

Cleared Dec 15, 1999

Microbiology · 64d

Cleared Dec 14, 1999

Microbiology · 63d

Cleared Dec 14, 1999

BACT/ALERT MP PROCESS BOTTLE

Microbiology · 54d

Cleared Sep 24, 1999

Microbiology · 65d

Cleared Sep 15, 1999

NUCLISENS CMV PP67

Microbiology · 324d

Cleared Sep 03, 1999

Microbiology · 46d

Cleared Sep 03, 1999

Microbiology · 46d

Cleared Jan 13, 1999

MB/BACT BLOOD CULTURE BOTTLE

Microbiology · 79d

Cleared Aug 18, 1998

MB/BACT BLOOD CULTURE BOTTLE

Microbiology · 50d

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