COBAS INTEGRA CREATININE PLUS VER.2 ASSAY


Device Classification Name

enzymatic method, creatinine

510(k) Number K024098
Device Name COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis, 
IN 
46250

Original Contact sherri l coenen
Regulation Number 862.1225
Classification Product Code
JFY  
Date Received 12/12/2002
Decision Date 12/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No