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510(k) K954202

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS by Medtronic Hemotec, Inc. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1996
Date Received
September 7, 1995
Clearance Type
Traditional
Expedited Review
Yes
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Medtronic Hemotec, Inc.

  • K944115 — HEPARIN ASSAY CARTRIDGES AND CONTROLS (March 24, 1995)
  • K940426 — MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (September 20, 1994)
  • K923594 — CLOTTRAC COAGULATION CONTROL (September 21, 1992)
  • K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)

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