HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806— 510(k) K925550

Name: FDA 510(k) clearance K925550
Creator: U.S. Food and Drug Administration
Published: 1993-04-20

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K925550 for HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806, Substantially Equivalent on 1993-04-20. Applicant: Hichem Diagnostics. Device class: 2.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code CDS
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1992-11-03
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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