HYBRID CAPTURE II CT/GC TEST— 510(k) K981567

Substantially Equivalent

Digene Corp.

FDA 510(k) clearance K981567 for HYBRID CAPTURE II CT/GC TEST, Substantially Equivalent on 2000-02-29. 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: 1998-05-01
Decision date: 2000-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beltsville, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Digene Corp.

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