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510(k) K923594

CLOTTRAC COAGULATION CONTROL by Medtronic Hemotec, Inc. — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1992
Date Received
July 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

Other clearances by Medtronic Hemotec, Inc.

  • K954202 — PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS (June 20, 1996)
  • K944115 — HEPARIN ASSAY CARTRIDGES AND CONTROLS (March 24, 1995)
  • K940426 — MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (September 20, 1994)
  • K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)

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  • K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER O (August 31, 2000)
  • K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (March 28, 2000)
  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYST (January 14, 2000)