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510(k) K023744

WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 by Wiener Laboratories Saic — Product Code JHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2003
Date Received
November 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Method, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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