HSV IDR— 510(k) K854974

Substantially Equivalent

Genus Diagnostics

FDA 510(k) clearance K854974 for HSV IDR, Substantially Equivalent on 1986-03-07. Applicant: Genus Diagnostics.

Clearance details

Applicant: Genus Diagnostics
Product code: Code GQN
Advisory panel: Microbiology
Date received: 1985-12-12
Decision date: 1986-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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