TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE— 510(k) K853244

Name: FDA 510(k) clearance K853244
Creator: U.S. Food and Drug Administration
Published: 1985-08-12

Substantially Equivalent

Simmler, Inc.

FDA 510(k) clearance K853244 for TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE, Substantially Equivalent on 1985-08-12. Applicant: Simmler, Inc.. Device class: 2.

Clearance details

Applicant: Simmler, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1985-08-01
Decision date: 1985-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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