SERUM, IGM ANTI-HUMAN ACID— 510(k) K760147

Name: FDA 510(k) clearance K760147
Creator: U.S. Food and Drug Administration
Published: 1976-07-20

Substantially Equivalent

Oxford Laboratories, Inc.

FDA 510(k) clearance K760147 for SERUM, IGM ANTI-HUMAN ACID, Substantially Equivalent on 1976-07-20. Applicant: Oxford Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Oxford Laboratories, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1976-06-29
Decision date: 1976-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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