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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