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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name U.V. Method, Cpk Isoenzymes
510(k) Number K810861
Device Name CREATINE KINASE MB ISOENZYME IMMUNO UV
Applicant
THE DOW CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE DOW CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1215
Classification Product Code
JHW  
Date Received03/31/1981
Decision Date 04/14/1981
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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