ANTI-GM & ANTI-KM TYPING SERUMS— 510(k) K812076

Name: FDA 510(k) clearance K812076
Creator: U.S. Food and Drug Administration
Published: 1981-08-12

Substantially Equivalent

Biotest-Serum-Institut

FDA 510(k) clearance K812076 for ANTI-GM & ANTI-KM TYPING SERUMS, Substantially Equivalent on 1981-08-12. Applicant: Biotest-Serum-Institut. Device class: 2.

Clearance details

Applicant: Biotest-Serum-Institut
Product code: Code DGH
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1981-07-22
Decision date: 1981-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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