ENZYMATIC CO2 REAGENT SET— 510(k) K882497

Name: FDA 510(k) clearance K882497
Creator: U.S. Food and Drug Administration
Published: 1988-08-02

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K882497 for ENZYMATIC CO2 REAGENT SET, Substantially Equivalent on 1988-08-02. Applicant: American Monitor Corp.. Device class: 2.

Clearance details

Applicant: American Monitor Corp.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1988-06-17
Decision date: 1988-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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