RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM— 510(k) K911444

Name: FDA 510(k) clearance K911444
Creator: U.S. Food and Drug Administration
Published: 1991-08-30

Substantially Equivalent

Wampole Laboratories

FDA 510(k) clearance K911444 for RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM, Substantially Equivalent on 1991-08-30. Applicant: Wampole Laboratories. Device class: 2.

Clearance details

Applicant: Wampole Laboratories
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1991-04-01
Decision date: 1991-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

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