ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)— 510(k) K873868

Name: FDA 510(k) clearance K873868
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K873868 for ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID), Substantially Equivalent on 1987-10-20. Applicant: Unipath , Ltd.. Device class: 1.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code LKL
Device class: Class 1
Regulation: 21 CFR 866.5420
Advisory panel: Immunology
Date received: 1987-08-24
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford Mk41 Oqg, GB

Download summary PDF View on FDA.gov ↗

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K922417 — AL-ACID GLYCOPROTEIN RID KIT1992-08-20
K904175 — RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT1990-11-13

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