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510(k) K893419

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) by Coulter Immunology — Product Code DEW

K893419 is an FDA 510(k) premarket notification submitted by Coulter Immunology for the device "COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Coulter Immunology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
May 2, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Coulter Immunology

  • K922744 — CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 (February 5, 1993)
  • K922745 — CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 (February 5, 1993)
  • K910473 — CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC (October 31, 1991)
  • K911793 — COULTERCLONE (July 9, 1991)
  • K893853 — COULTER CLONE T8 MONOCLONAL ANTIBODY (March 2, 1990)
  • K893852 — COULTER CLONE T4 MONOCLONAL ANTIBODY (March 2, 1990)
  • K894179 — COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY (February 12, 1990)
  • K895917 — CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI (December 29, 1989)
  • K884605 — COULTER CLONE MO2 (August 15, 1989)
  • K883753 — COULTER CLONE T1 MONOCLONAL ANTIBODY (February 3, 1989)

Other clearances for product code DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources