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510(k) K911610

ELISA COMBI-KIT HUMAN IGG SUBCLASSES by Janssen Research Foundation — Product Code DEW

K911610 is an FDA 510(k) premarket notification submitted by Janssen Research Foundation for the device "ELISA COMBI-KIT HUMAN IGG SUBCLASSES". The FDA issued a decision of Substantially Equivalent on June 12, 1991. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1991
Date Received
March 25, 1991
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 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