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510(k) K955638

SYNTHAFAX APTT REAGENT by Ortho Diagnostic Systems, Inc. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
December 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
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)
  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (November 29, 1996)
  • K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (May 13, 1996)
  • K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL 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)

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  • K053111 — STA-CEPHASCREEN KIT (May 4, 2006)
  • K060688 — HEMOSIL SYNTHASIL (April 13, 2006)
  • K050221 — HEMOSIL SILICA CLOTTING TIME (March 30, 2005)
  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
  • K014028 — CARESIDE APTT (February 8, 2002)
  • K014008 — HEMOCHRON JR. CITRATE APTT CUVETTE (January 24, 2002)
  • K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (December 6, 1999)