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510(k) K944115

HEPARIN ASSAY CARTRIDGES AND CONTROLS by Medtronic Hemotec, Inc. — Product Code GFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
August 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protamine Sulphate
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by Medtronic Hemotec, Inc.

  • K954202 — PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS (June 20, 1996)
  • 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)

Other clearances for product code GFT

  • K910105 — PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 (February 26, 1991)