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510(k) K020798

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

K020798 is an FDA 510(k) premarket notification submitted by International Technidyne Corp. for the device "HEMOCHRON JR. SIGNATURE +". The FDA issued a decision of Substantially Equivalent on March 28, 2002. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. International Technidyne Corp. has at least 10 other 510(k) clearances on record.

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.

  • 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)
  • 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

  • K253658 — STA Satellite Max® (April 27, 2026)
  • 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)

FDA data resources