ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K000900
Device Name ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
Original Applicant
ELAN HOLDINGS, INC.
231 north puente st.
brea, 
CA 
92821

Original Contact wynn stocking
Regulation Number 862.1175
Classification Product Code
CHH  
Date Received 03/21/2000
Decision Date 05/02/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No