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510(k) K923921

IL TEST PT FIBRINOGEN HS by Instrumentation Laboratory CO — Product Code GIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1992
Date Received
August 5, 1992
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

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Other clearances for product code GIS

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  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (November 29, 1996)
  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K925494 — BIOMERIEUX HEMOLAB FIBRINOMAT (May 18, 1993)
  • K913061 — FIBRINOGEN DETERMINATION KIT (October 9, 1991)
  • K910636 — ABS CADKIT (April 29, 1991)
  • K903874 — FIBRINOTEST(TM) - FIBRINOGEN ASSAY (February 14, 1991)
  • K881685 — FIBRINOGENTEST-O (August 9, 1988)