RUBELLA HEMAGGLUTINATION REAGENT KIT— 510(k) K771957

Name: FDA 510(k) clearance K771957
Creator: U.S. Food and Drug Administration
Published: 1977-10-28

Substantially Equivalent

Flow Laboratories, Inc.

FDA 510(k) clearance K771957 for RUBELLA HEMAGGLUTINATION REAGENT KIT, Substantially Equivalent on 1977-10-28. Applicant: Flow Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Flow Laboratories, Inc.
Product code: Code GOK
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1977-10-17
Decision date: 1977-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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