ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS— 510(k) K000958

Clearance details

Applicant

Elan Holdings, Inc.

Product code

Code CDQ

Device class

Class 2

Regulation

21 CFR 862.1770

Advisory panel

Clinical Chemistry

Date received

2000-03-24

Decision date

2000-05-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Brea, CA, US

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