Medical Device Manufacturer · US , Gaithersburg , MD

Digene Corp. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1997

Total

Cleared

Denied

Digene Corp. has 9 FDA 510(k) cleared medical devices. Based in Gaithersburg, US.

Historical record: 9 cleared submissions from 1997 to 2001. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Digene Corp. Filter by specialty or product code using the sidebar.

Digene Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Digene Corp.

9 devices

1-9 of 9

Cleared Sep 25, 2001

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

K010891 · LSK

Microbiology · 183d

Cleared Sep 24, 2001

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

K010892 · LSK

Microbiology · 182d

Cleared Sep 24, 2001

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

K010893 · LSL

Microbiology · 182d

Cleared Feb 29, 2000

HYBRID CAPTURE II CT/GC TEST

K981567 · LSL

Microbiology · 669d

Cleared Nov 29, 1999

HYBRID CAPTURE II GC-ID

K981485 · LSL

Microbiology · 584d

Cleared Oct 25, 1999

HYBRID CAPTURE II CT-ID TEST

K990023 · LSK

Microbiology · 293d

Cleared Sep 29, 1998

HYBRID CAPTURE SYSTEM CMV DNA ASSAY

K974901 · LJO

Microbiology · 272d

Cleared Feb 06, 1998

DIGENE DML 2000 MICROPLATE LUMINOMETER

K980120 · JJQ

Chemistry · 24d

Cleared Sep 19, 1997

DIGENE CERVICAL BRUSH

K971586 · HHT

Obstetrics & Gynecology · 141d

Digene Corp. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Digene Corp.

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