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510(k) K022757

SPIFE CK KIT, MODEL 3332, 3333 by Helena Laboratories — Product Code JHY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
August 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K070835 — OLYMPUS CK-MB REAGENT (June 4, 2007)
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  • K974421 — ELECSYS CK-MB STAT (December 17, 1997)
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  • K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (June 18, 1996)
  • K951638 — AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (May 2, 1995)