Home / 510(k) Clearances / K963902

510(k) K963902

QUANTITATIVE FIBRINOGEN ASSAY by Ortho Diagnostic Systems, Inc. — Product Code GIS

K963902 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "QUANTITATIVE FIBRINOGEN ASSAY". The FDA issued a decision of Substantially Equivalent on November 29, 1996. The device falls under product code GIS (Test, Fibrinogen), a Class II device regulated under 21 CFR 864.7340. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1996
Date Received
September 27, 1996
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 Ortho Diagnostic Systems, Inc.

  • K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (July 14, 1997)
  • K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (March 6, 1997)
  • K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (January 22, 1997)
  • K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) (May 10, 1996)
  • K935720 — ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTE (May 9, 1996)
  • K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (April 30, 1996)
  • K955638 — SYNTHAFAX APTT REAGENT (April 23, 1996)

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)
  • 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)
  • K881685 — FIBRINOGENTEST-O (August 9, 1988)

FDA data resources