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510(k) K940422

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER by The Binding Site, Ltd. — Product Code DFZ

K940422 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER". The FDA issued a decision of Substantially Equivalent on May 27, 1994. The device falls under product code DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
January 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by The Binding Site, Ltd.

  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)
  • K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (December 20, 2013)
  • K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (February 27, 2012)
  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MOD (December 30, 2009)
  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (February 10, 2009)
  • K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (December 19, 2008)

Other clearances for product code DFZ

  • K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION (October 21, 2009)
  • K021081 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIME (June 17, 2002)
  • K020823 — PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (May 14, 2002)
  • K955906 — BOEHRINGER MANNHEIM IGG ASSAY (February 9, 1996)
  • K812821 — H-103 IGG, H-104 IGA, H-105 IGM (October 26, 1981)
  • K803272 — AUTOMATED IMMUNOPRECIPITIN METHOD/ICG (January 26, 1981)
  • K790709 — ANTISERUM TO RABBIT IMMUNOGLOBULIN (August 16, 1979)
  • K790720 — ANTISERA TO RABBIT IMMUNOGLOBULIN (August 16, 1979)

FDA data resources