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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 K950186
Device Name CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
Applicant
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number862.1215
Classification Product Code
JHW  
Date Received01/17/1995
Decision Date 03/13/1995
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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