MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

Dna-reagents, Neisseria

DIGENE CORP.

The following data is part of a premarket notification filed by Digene Corp. with the FDA for Modification To Hybrid Capture 2 Gc-id Dna Test, Model 03m92-01.

Pre-market Notification Details

Device IDK010893
510k NumberK010893
Device Name:MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01
ClassificationDna-reagents, Neisseria
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 CodeLSL  
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-26
Decision Date2001-09-24

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