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510(k) K931050

CARDIO REP CK ISOENZYME KIT - 3310 by Helena Laboratories — Product Code JHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
March 1, 1993
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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