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

Dna-reagents, Chlamydia

DIGENE CORP.

The following data is part of a premarket notification filed by Digene Corp. with the FDA for Modification To Hybrid Capture Ii Ct/gc Test, Model 03m90-01.

Pre-market Notification Details

Device IDK010891
510k NumberK010891
Device Name:MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01
ClassificationDna-reagents, Chlamydia
Applicant DIGENE CORP. 1201 CLOPPER RD. Gaithersburg,  MD  20878
ContactMark A Del Vecchio
CorrespondentMark A Del Vecchio
DIGENE CORP. 1201 CLOPPER RD. Gaithersburg,  MD  20878
Product CodeLSK  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-26
Decision Date2001-09-25

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