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510(k) K821898

ORTHO CLASSICAL PATHWAY COMPL. TEST by Ortho Diagnostic Systems, Inc. — Product Code DBA

K821898 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO CLASSICAL PATHWAY COMPL. TEST". The FDA issued a decision of Substantially Equivalent on July 16, 1982. The device falls under product code DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5250. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1982
Date Received
June 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5250
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 DBA

  • K141100 — OPTILITE C1 INACTIVATOR KIT (July 18, 2014)
  • K122304 — HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (April 15, 2013)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)
  • K011780 — K-ASSAY C1-INA (July 25, 2001)
  • K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE (March 19, 2001)
  • K965024 — N-ASSAY TIA C1-INACTIVATOR TEST KIT (July 14, 1997)
  • K960257 — N ANTISERUM TO C1 INHIBITOR (August 1, 1996)
  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K915431 — COMPLEMENT C1 INACTIVATOR KIT (January 17, 1992)
  • K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (July 23, 1987)

FDA data resources