GAMMA LEWIS BLOOD GROUP SUBSTANCE— 510(k) K802533

Name: FDA 510(k) clearance K802533
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K802533 for GAMMA LEWIS BLOOD GROUP SUBSTANCE, Substantially Equivalent on 1980-11-12. Applicant: Gamma Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code KSX
Device class: Class 2
Regulation: 21 CFR 864.9160
Advisory panel: Hematology
Date received: 1980-10-15
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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