ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)— 510(k) K801098

Name: FDA 510(k) clearance K801098
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Flow Laboratories, Inc.

FDA 510(k) clearance K801098 for ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES), Substantially Equivalent on 1980-09-16. Applicant: Flow Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Flow Laboratories, Inc.
Product code: Code GOL
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1980-05-09
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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