ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR


Device Classification Name

alkaline picrate, colorimetry, creatinine

510(k) Number K023407
Device Name ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
Original Applicant
ELAN DIAGNOSTICS
1075 w. lambert rd., suite d
brea, 
CA 
92821

Original Contact wynn stocking
Regulation Number 862.1225
Classification Product Code
CGX  
Subsequent Product Code
JIS  
Date Received 10/10/2002
Decision Date 02/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No