SERIMM SURE ASO-CHEK CONTROL SERUM— 510(k) K842839

Name: FDA 510(k) clearance K842839
Creator: U.S. Food and Drug Administration
Published: 1984-08-23

Substantially Equivalent

Analytical Products, Inc.

FDA 510(k) clearance K842839 for SERIMM SURE ASO-CHEK CONTROL SERUM, Substantially Equivalent on 1984-08-23. Applicant: Analytical Products, Inc.. Device class: 1.

Clearance details

Applicant: Analytical Products, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1984-07-20
Decision date: 1984-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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