VIROGEN RUBELLA SLIDE TEST— 510(k) K844435

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K844435 for VIROGEN RUBELLA SLIDE TEST, Substantially Equivalent on 1985-05-20. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code LQN
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1984-11-16
Decision date: 1985-05-20
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.