MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01— 510(k) K010893

Name: FDA 510(k) clearance K010893
Creator: U.S. Food and Drug Administration
Published: 2001-09-24

Substantially Equivalent

Digene Corp.

FDA 510(k) clearance K010893 for MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01, Substantially Equivalent on 2001-09-24. Applicant: Digene Corp.. Device class: 2.

Clearance details

Applicant: Digene Corp.
Product code: Code LSL
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 2001-03-26
Decision date: 2001-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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