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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 K023744
Device Name WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
Applicant
Wiener Laboratories Saic
2944 Riobamba
Rosario, Santa Fe,  AR 2000
Applicant Contact VIVIANA CETOLA
Correspondent
Wiener Laboratories Saic
2944 Riobamba
Rosario, Santa Fe,  AR 2000
Correspondent Contact VIVIANA CETOLA
Regulation Number862.1215
Classification Product Code
JHW  
Date Received11/07/2002
Decision Date 01/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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