CREATININE (RATE) REAGENT SET— 510(k) K905619

Name: FDA 510(k) clearance K905619
Creator: U.S. Food and Drug Administration
Published: 1991-02-13

Substantially Equivalent

Biochemical Trade, Inc.

FDA 510(k) clearance K905619 for CREATININE (RATE) REAGENT SET, Substantially Equivalent on 1991-02-13. Applicant: Biochemical Trade, Inc.. Device class: 2.

Clearance details

Applicant: Biochemical Trade, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1990-12-14
Decision date: 1991-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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