MULTICHEM ALKALINE PHOSPHATASE (S0903)— 510(k) K873761

Name: FDA 510(k) clearance K873761
Creator: U.S. Food and Drug Administration
Published: 1987-10-07

Substantially Equivalent

Simmler, Inc.

FDA 510(k) clearance K873761 for MULTICHEM ALKALINE PHOSPHATASE (S0903), Substantially Equivalent on 1987-10-07. Applicant: Simmler, Inc.. Device class: 2.

Clearance details

Applicant: Simmler, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1987-09-16
Decision date: 1987-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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