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510(k) K945078

HEMOCHRON HNPT/FACTOR VI PT+ by International Technidyne Corp. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1995
Date Received
October 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

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  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (April 13, 1999)
  • K972866 — HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT (September 30, 1998)

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