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510(k) K961835

PROTIME MICROCOAGULATION SYSTEM by International Technidyne Corp. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1997
Date Received
May 13, 1996
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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