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510(k) K930359

CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 by Helena Laboratories — Product Code JHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K872041 — COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (September 16, 1987)
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