Home / 510(k) Clearances / K050016

510(k) K050016

HEMOCHRON SIGNATURE ELITE by International Technidyne Corp. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2005
Date Received
January 4, 2005
Clearance Type
Traditional
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.

  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • 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)
  • K974799 — HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE (July 7, 1998)

Other clearances for product code JPA

  • K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) (June 2, 2025)
  • K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (April 30, 2025)
  • K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (January 15, 2025)
  • K232018 — Citrated: K, KH, RTH, FFH (March 29, 2024)
  • K233790 — ACL TOP 970 CL (December 29, 2023)
  • K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein (September 29, 2023)
  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K201440 — ROTEM sigma Thromboelastometry System (July 8, 2022)
  • K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A (December 29, 2021)
  • K193041 — Hemochron Signature Elite (November 22, 2019)