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Digene Corp.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K010891	MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01	LSK	2001-09-25	View
510(k)	K010892	MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01	LSK	2001-09-24	View
510(k)	K010893	MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01	LSL	2001-09-24	View
510(k)	K981567	HYBRID CAPTURE II CT/GC TEST	LSL	2000-02-29	View
510(k)	K981485	HYBRID CAPTURE II GC-ID	LSL	1999-11-29	View
510(k)	K990023	HYBRID CAPTURE II CT-ID TEST	LSK	1999-10-25	View
510(k)	K974901	HYBRID CAPTURE SYSTEM CMV DNA ASSAY	LJO	1998-09-29	View
510(k)	K980120	DIGENE DML 2000 MICROPLATE LUMINOMETER	JJQ	1998-02-06	View
510(k)	K971586	DIGENE CERVICAL BRUSH	HHT	1997-09-19	View

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