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510(k) K900126

TT AND HNTT BY HEMOCHRON by International Technidyne Corp. — Product Code GJA

K900126 is an FDA 510(k) premarket notification submitted by International Technidyne Corp. for the device "TT AND HNTT BY HEMOCHRON". The FDA issued a decision of Substantially Equivalent on February 5, 1990. The device falls under product code GJA (Test, Thrombin Time), a Class II device regulated under 21 CFR 864.7875. International Technidyne Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1990
Date Received
January 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Thrombin Time
Device Class
Class II
Regulation Number
864.7875
Review Panel
HE
Submission Type

Other clearances by International Technidyne Corp.

  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K050016 — HEMOCHRON SIGNATURE ELITE (February 10, 2005)
  • K030818 — HEMOCHRON RESPONSE/SYSTEM (April 2, 2003)
  • K023561 — ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM (January 31, 2003)
  • K020798 — HEMOCHRON JR. SIGNATURE + (March 28, 2002)
  • 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)

Other clearances for product code GJA

  • K050817 — T-TEK (December 12, 2005)
  • K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (October 15, 1998)
  • K970645 — BC THROMBIN REAGENT (May 19, 1997)
  • K925493 — BIOMERIEUX HEMOLAB THROMBICALCI-TEST (April 21, 1994)
  • K930157 — TEST THROMBIN (May 14, 1993)
  • K923220 — THROMBIN CLOT TIME TEST PROCEDURE (September 29, 1992)
  • K920147 — THROMBIN CLOTTING TIME REAGENT (May 1, 1992)
  • K894467 — THROMBIN TIME REAGENT (September 5, 1989)
  • K884385 — FIBRI-PREST/THROMBIN-PREST CONTROLS (December 28, 1988)
  • K884384 — THROMBIN-PREST REAGENT KIT (December 28, 1988)

FDA data resources