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510(k) K020798

HEMOCHRON JR. SIGNATURE + by International Technidyne Corp. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2002
Date Received
March 12, 2002
Clearance Type
Special
Expedited Review
No
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 International Technidyne Corp.

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  • K030818 — HEMOCHRON RESPONSE/SYSTEM (April 2, 2003)
  • K023561 — ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM (January 31, 2003)
  • K010599 — PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE (July 2, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)
  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (April 13, 1999)
  • K972866 — HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT (September 30, 1998)
  • K974799 — HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE (July 7, 1998)

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