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510(k) K881685

FIBRINOGENTEST-O by Diatech, Inc. — Product Code GIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1988
Date Received
April 19, 1988
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 Diatech, Inc.

  • K854938 — COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. (March 12, 1986)
  • K854089 — DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT (January 6, 1986)
  • K854090 — DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT (January 6, 1986)
  • K842286 — DIA T1, T2 & T3 (September 11, 1984)
  • K841462 — HEPARIN COAGULATION CONTROL PLASMA 1- (June 1, 1984)
  • K841523 — OWREN'S VERONAL BUFFERR (June 1, 1984)
  • K841366 — DIA FIBRIN (June 1, 1984)
  • K841365 — DIA REPTIN (June 1, 1984)
  • K841461 — COAGULATION CONTROL PLASMA LEVEL 1/2/3 (May 2, 1984)
  • K840802 — DIA THROMBIN DIA PLASTIN (May 1, 1984)

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  • 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)