ATAC PAK AST REAGENT KIT— 510(k) K010488

Substantially Equivalent

Elan Holdings, Inc.

FDA 510(k) clearance K010488 for ATAC PAK AST REAGENT KIT, Substantially Equivalent on 2001-04-09. Applicant: Elan Holdings, Inc..

Clearance details

Applicant
Elan Holdings, Inc.
Product code
Code CIT
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
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