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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 K880178
Device Name CREATINE KINASE (COLORIMETRIC METHOD)
Applicant
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Applicant Contact HAPPY CHEN
Correspondent
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Correspondent Contact HAPPY CHEN
Regulation Number862.1215
Classification Product Code
JHY  
Date Received01/15/1988
Decision Date 02/18/1988
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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