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510(k) K853789

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR by Hemotec, Inc. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
September 10, 1985
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 Hemotec, Inc.

  • K902081 — CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL (July 3, 1990)
  • K894317 — HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. (September 5, 1989)
  • 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)
  • K854377 — HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)
  • K854376 — HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)
  • K843459 — HEMOTEC ACT I SYSTEM (December 12, 1984)

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  • K232018 — Citrated: K, KH, RTH, FFH (March 29, 2024)
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  • 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)
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