HICHEM TOTAL PROTEIN REAGENT— 510(k) K992846

Name: FDA 510(k) clearance K992846
Creator: U.S. Food and Drug Administration
Published: 1999-10-18

Substantially Equivalent

Elan Holdings, Inc.

FDA 510(k) clearance K992846 for HICHEM TOTAL PROTEIN REAGENT, Substantially Equivalent on 1999-10-18. Applicant: Elan Holdings, Inc.. Device class: 2.

Clearance details

Applicant: Elan Holdings, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1999-08-24
Decision date: 1999-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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