MULTICHEM CREATININE REAGENT S0917— 510(k) K873725

Name: FDA 510(k) clearance K873725
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Simmler, Inc.

FDA 510(k) clearance K873725 for MULTICHEM CREATININE REAGENT S0917, Substantially Equivalent on 1987-10-20. Applicant: Simmler, Inc.. Device class: 2.

Clearance details

Applicant: Simmler, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1987-09-15
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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