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510(k) K941001

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

K941001 is an FDA 510(k) premarket notification submitted by Diagnostic Specialties for the device "ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on August 30, 1994. The device falls under product code GIS (Test, Fibrinogen), a Class II device regulated under 21 CFR 864.7340. Diagnostic Specialties has at least 7 other 510(k) clearances on record.

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

Other clearances by Diagnostic Specialties

  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • K930823 — PROTEIN-BOUND GLUCOSE ASSAYN KIT (August 19, 1993)
  • K922032 — ENZIP URINARY MICROALBUMIN TEST (July 30, 1992)
  • K831180 — PREGNA-CERT, SLIDE PREGNANCY TEST (May 27, 1983)
  • K823109 — GENERIC PREGNANCY TEST (November 10, 1982)
  • K813608 — POTASSIUM REAGENT SET (January 22, 1982)
  • K813412 — GLUCOSE ENZYME-COLOR REAGENT SET (December 31, 1981)

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)
  • 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)

FDA data resources