Medical Device Manufacturer · GB , Cambridgeshire

Dako Diagnostics , Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1993

Recent clearances: IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3, IMAGEN RESPIRATORY SCREEN

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dako Diagnostics , Ltd. Microbiology ✕

6 devices

1-6 of 6

Cleared Sep 28, 1998

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA...

Microbiology · 188d

Cleared Dec 22, 1997

IMAGEN RESPIRATORY SCREEN

Microbiology · 74d

Cleared Dec 26, 1996

IMAGEN RESPIRATORY SCREEN

Microbiology · 216d

Cleared Jan 11, 1996

IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION

Microbiology · 707d

Cleared Jan 09, 1995

Microbiology · 171d

Cleared Dec 27, 1993

IDEIA(TM) ROTAVIRUS

Microbiology · 224d