ATAC PAK AST REAGENT KIT


Device Classification Name

nadh oxidation/nad reduction, ast/sgot

510(k) Number K010488
Device Name ATAC PAK AST REAGENT KIT
Original Applicant
ELAN HOLDINGS, INC.
231 north puente st.
brea, 
CA 
92821

Original Contact wynn stocking
Regulation Number 862.1100
Classification Product Code
CIT  
Date Received 02/20/2001
Decision Date 04/09/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized