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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 K890295
Device Name TARGET(TM) CK-MB
Applicant
V-Tech, Inc.
9440 Telstar Ave., Suite 7
El Monte,  CA  91731
Applicant Contact K BRUNKHORST
Correspondent
V-Tech, Inc.
9440 Telstar Ave., Suite 7
El Monte,  CA  91731
Correspondent Contact K BRUNKHORST
Regulation Number862.1215
Classification Product Code
JHY  
Date Received01/19/1989
Decision Date 08/15/1989
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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