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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K022654
Device Name MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Po Bx 50457
Indianapolis,  IN  46250
Applicant Contact SHERRI L COENEN
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Po Bx 50457
Indianapolis,  IN  46250
Correspondent Contact SHERRI L COENEN
Regulation Number862.1215
Classification Product Code
JHY  
Date Received08/09/2002
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
Predetermined Change
Control Plan Authorized		 No
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