DeviceClearance

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS— 510(k) K000556

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K000556 for ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS, Substantially Equivalent on 2000-05-17. Applicant: Elan Diagnostics.

Clearance details

Applicant
Elan Diagnostics
Product code
Code CFR
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brea, CA, US
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