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FDA 510(k) Applications Submitted by DIGENE CORP.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K980120
01/13/1998
DIGENE DML 2000 MICROPLATE LUMINOMETER
DIGENE CORP.
K971586
05/01/1997
DIGENE CERVICAL BRUSH
DIGENE CORP.
K974901
12/31/1997
HYBRID CAPTURE SYSTEM CMV DNA ASSAY
DIGENE CORP.
K990023
01/05/1999
HYBRID CAPTURE II CT-ID TEST
DIGENE CORP.
K010891
03/26/2001
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
DIGENE CORP.
K010892
03/26/2001
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
DIGENE CORP.
K010893
03/26/2001
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
DIGENE CORP.
K981485
04/24/1998
HYBRID CAPTURE II GC-ID
DIGENE CORP.
K981567
05/01/1998
HYBRID CAPTURE II CT/GC TEST
DIGENE CORP.
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