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Digene Corp.

9 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (K010891)Digene Corp.2001-09-25
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (K010892)Digene Corp.2001-09-24
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 (K010893)Digene Corp.2001-09-24
HYBRID CAPTURE II CT/GC TEST (K981567)Digene Corp.2000-02-29
HYBRID CAPTURE II GC-ID (K981485)Digene Corp.1999-11-29
HYBRID CAPTURE II CT-ID TEST (K990023)Digene Corp.1999-10-25
HYBRID CAPTURE SYSTEM CMV DNA ASSAY (K974901)Digene Corp.1998-09-29
DIGENE DML 2000 MICROPLATE LUMINOMETER (K980120)Digene Corp.1998-02-06
DIGENE CERVICAL BRUSH (K971586)Digene Corp.1997-09-19

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Every clearance here is in the API, with alerts when new ones post.