ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU— 510(k) K781023

Name: FDA 510(k) clearance K781023
Creator: U.S. Food and Drug Administration
Published: 1978-08-14

Substantially Equivalent

Icl Scientific

FDA 510(k) clearance K781023 for ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU, Substantially Equivalent on 1978-08-14. Applicant: Icl Scientific. Device class: 1.

Clearance details

Applicant: Icl Scientific
Product code: Code DEX
Device class: Class 1
Regulation: 21 CFR 866.5420
Advisory panel: Immunology
Date received: 1978-06-19
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN1976-07-20

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