CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM


Device Classification Name

enzymatic method, creatinine

510(k) Number K021428
Device Name CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
Original Applicant
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 862.1225
Classification Product Code
JFY  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIP  
JIR   JJB   JMT   JRE   KQO   LJX  
Date Received 05/03/2002
Decision Date 07/05/2002
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