IGM RHEUMATOID FACTOR TEST KIT— 510(k) K851099

Name: FDA 510(k) clearance K851099
Creator: U.S. Food and Drug Administration
Published: 1985-04-25

Substantially Equivalent

Breit Laboratories, Inc.

FDA 510(k) clearance K851099 for IGM RHEUMATOID FACTOR TEST KIT, Substantially Equivalent on 1985-04-25. Applicant: Breit Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Breit Laboratories, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1985-03-19
Decision date: 1985-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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