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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 K782015
Device Name A-GENT CK-MB
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number862.1215
Classification Product Code
JHW  
Date Received12/05/1978
Decision Date 02/01/1979
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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