MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB


Device Classification Name

colorimetric method, cpk or isoenzymes

510(k) Number K022654
Device Name MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
po bx 50457
indianapolis, 
IN 
46250 -0457

Original Contact sherri l coenen
Regulation Number 862.1215
Classification Product Code
JHY  
Date Received 08/09/2002
Decision Date 08/29/2002
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