RAICHEM BUN RATE REAGENT— 510(k) K012649

Name: FDA 510(k) clearance K012649
Creator: U.S. Food and Drug Administration
Published: 2001-10-15

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K012649 for RAICHEM BUN RATE REAGENT, Substantially Equivalent on 2001-10-15. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 2001-08-13
Decision date: 2001-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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