VIROGEN ROTATEST SLIDE TEST— 510(k) K853399

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K853399 for VIROGEN ROTATEST SLIDE TEST, Substantially Equivalent on 1985-11-12. Applicant: Armkel, LLC. Device class: 1.

Clearance details

Applicant: Armkel, LLC
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1985-08-12
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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