Medical Device Manufacturer · US , Gaithersburg , MD

Digene Corp. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1997

9

Total

9

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared Sep 25, 2001

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01

Microbiology · 183d

Cleared Sep 24, 2001

MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01

Microbiology · 182d

Cleared Sep 24, 2001

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

Microbiology · 182d

Cleared Feb 29, 2000

HYBRID CAPTURE II CT/GC TEST

Microbiology · 669d

Cleared Nov 29, 1999

HYBRID CAPTURE II GC-ID

Microbiology · 584d

Cleared Oct 25, 1999

HYBRID CAPTURE II CT-ID TEST

Microbiology · 293d

Cleared Sep 29, 1998

HYBRID CAPTURE SYSTEM CMV DNA ASSAY

Microbiology · 272d