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..

Clearance details

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

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