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510(k) K941001

ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT by Diagnostic Specialties — Product Code GIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1994
Date Received
March 1, 1994
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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  • K042919 — FIBROTEK FIB (November 29, 2004)
  • K993482 — K-ASSAY FIBRINOGEN (December 6, 1999)
  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (November 29, 1996)
  • 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)
  • K881685 — FIBRINOGENTEST-O (August 9, 1988)