APOLIPOPROTEIN A-I (APO A-I)— 510(k) K901675

Name: FDA 510(k) clearance K901675
Creator: U.S. Food and Drug Administration
Published: 1990-04-26

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K901675 for APOLIPOPROTEIN A-I (APO A-I), Substantially Equivalent on 1990-04-26. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code DEL
Device class: Class 1
Regulation: 21 CFR 866.5590
Advisory panel: Immunology
Date received: 1990-04-10
Decision date: 1990-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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