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510(k) K092450

HUMAN IGD KIT FOR USE ON SPAPLUS by The Binding Site — Product Code CZJ

K092450 is an FDA 510(k) premarket notification submitted by The Binding Site for the device "HUMAN IGD KIT FOR USE ON SPAPLUS". The FDA issued a decision of Substantially Equivalent on December 28, 2009. The device falls under product code CZJ (Igd, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. The Binding Site has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2009
Date Received
August 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by The Binding Site

  • 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)
  • 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)
  • K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (M (October 15, 2008)

Other clearances for product code CZJ

  • K051299 — IGD DIAGNOSTIC TEST KITS (November 23, 2005)
  • K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (October 26, 2000)
  • K913671 — HUMAN IGD IMMUNOLOGICAL NL TEST KIT (December 2, 1991)
  • K883001 — QM300 CALIBRATOR D PACK (September 22, 1988)
  • K872834 — TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (August 12, 1987)
  • K831956 — DETERM. SIZE 72 RADIAL-HUMAN IGD (July 18, 1983)
  • K772327 — LAS-R HUMAN IGD TEST (February 28, 1978)

FDA data resources