HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813— 510(k) K925553

Name: FDA 510(k) clearance K925553
Creator: U.S. Food and Drug Administration
Published: 1993-02-12

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K925553 for HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813, Substantially Equivalent on 1993-02-12. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code JFL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1992-11-03
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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