ATAC PAK CPK REAGENT KIT— 510(k) K012474

Substantially Equivalent

Elan Holdings, Inc.

FDA 510(k) clearance K012474 for ATAC PAK CPK REAGENT KIT, Substantially Equivalent on 2001-10-03. Applicant: Elan Holdings, Inc.. Device class: 2.

Clearance details

Applicant: Elan Holdings, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2001-08-02
Decision date: 2001-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.