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510(k) K894317

HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. by Hemotec, Inc. — Product Code JOX

K894317 is an FDA 510(k) premarket notification submitted by Hemotec, Inc. for the device "HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code JOX (Analyzer, Heparin, Automated), a Class II device regulated under 21 CFR 864.5680. Hemotec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Heparin, Automated
Device Class
Class II
Regulation Number
864.5680
Review Panel
HE
Submission Type

Other clearances by Hemotec, Inc.

  • K902081 — CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL (July 3, 1990)
  • K894466 — HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS (September 5, 1989)
  • K894359 — CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS (September 5, 1989)
  • K884590 — HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES (January 10, 1989)
  • K875089 — HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN (March 9, 1988)
  • K880302 — CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER (February 19, 1988)
  • K854376 — HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)
  • K854377 — HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)
  • K853789 — ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR (October 4, 1985)
  • K843459 — HEMOTEC ACT I SYSTEM (December 12, 1984)

Other clearances for product code JOX

  • K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (June 8, 2011)
  • K102953 — HEPARIN DOSE RESPONSE CARTRIDGE (November 4, 2010)
  • K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (October 13, 2010)
  • K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (May 24, 2005)
  • K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (December 3, 2004)
  • K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (October 1, 2004)
  • K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOIN (January 14, 2000)
  • K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)
  • K911240 — HEPCON HMS WITH BODY SURFACE AREA CALCULATION (July 17, 1991)
  • K854377 — HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)

FDA data resources