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510(k) K781880

ASSAY KIT, THROMBO-SCREEN by Pacific Hemostasis — Product Code GIS

K781880 is an FDA 510(k) premarket notification submitted by Pacific Hemostasis for the device "ASSAY KIT, THROMBO-SCREEN". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code GIS (Test, Fibrinogen), a Class II device regulated under 21 CFR 864.7340. Pacific Hemostasis has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
November 6, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Fibrinogen
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

Other clearances by Pacific Hemostasis

  • K000679 — THROMBOSTRATE CONTROL PLASMAS (March 24, 2000)
  • K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D (February 18, 2000)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K992278 — HEPARIN CONTROL PLASMA LEVEL 1 (August 26, 1999)
  • K992279 — HEPARIN CONTROL PLASMA LEVEL 2 (August 26, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K990046 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA (February 17, 1999)
  • K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL) (December 1, 1998)
  • K984130 — COAGULATION CONTROL LEVEL 2 (ABNORMAL) (December 1, 1998)
  • K984131 — COAGULATION CONTROL LEVEL 3 (ABNORMAL) (December 1, 1998)

Other clearances for product code GIS

  • K143470 — Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen (January 31, 2016)
  • K042919 — FIBROTEK FIB (November 29, 2004)
  • K993482 — K-ASSAY FIBRINOGEN (December 6, 1999)
  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (November 29, 1996)
  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K925494 — BIOMERIEUX HEMOLAB FIBRINOMAT (May 18, 1993)
  • K923921 — IL TEST PT FIBRINOGEN HS (October 26, 1992)
  • K913061 — FIBRINOGEN DETERMINATION KIT (October 9, 1991)
  • K910636 — ABS CADKIT (April 29, 1991)
  • K903874 — FIBRINOTEST(TM) - FIBRINOGEN ASSAY (February 14, 1991)

FDA data resources