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510(k) K821949

ORTHO* ALTERNATIVE PATHWAY COMPL. TEST by Ortho Diagnostic Systems, Inc. — Product Code DAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1982
Date Received
June 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1q, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
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)
  • 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)
  • K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) 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)

Other clearances for product code DAK

  • K031563 — BINDAZYME CLQ CIC EIA KIT (September 10, 2003)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)
  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODI (September 30, 1998)
  • K972873 — IMMUSTRIP HAMA IGG (March 17, 1998)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K914388 — C1 RID KIT (October 28, 1991)
  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K864312 — IC MICROASSAY (January 9, 1987)