K012474

Substantially Equivalent

ATAC PAK CPK REAGENT KIT

Applicant: Elan Holdings, Inc.
Product 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

Download summary PDF View on FDA.gov ↗

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