HYBRID CAPTURE SYSTEM CMV DNA ASSAY— 510(k) K974901

Name: FDA 510(k) clearance K974901
Creator: U.S. Food and Drug Administration
Published: 1998-09-29

Substantially Equivalent

Digene Corp.

FDA 510(k) clearance K974901 for HYBRID CAPTURE SYSTEM CMV DNA ASSAY, Substantially Equivalent on 1998-09-29. Applicant: Digene Corp.. Device class: 2.

Clearance details

Applicant: Digene Corp.
Product code: Code LJO
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1997-12-31
Decision date: 1998-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beltsville, MD, US

Download summary PDF View on FDA.gov ↗

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