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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic Separation, Cpk Isoenzymes
510(k) Number K872041
Device Name COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
Applicant
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact RICHARDSON-JONES
Regulation Number862.1215
Classification Product Code
JHT  
Date Received05/27/1987
Decision Date 09/16/1987
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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