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

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..

Clearance details

Applicant: Digene Corp.
Product code: Code LJO
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.