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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K945083
Device Name ACCESS CK-MB REAGENTS
Applicant
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact JAN OLSEN
Correspondent
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact JAN OLSEN
Regulation Number862.1215
Classification Product Code
JHS  
Date Received10/17/1994
Decision Date 11/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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