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510(k) K881174

RID PLATE READER by The Binding Site, Ltd. — Product Code JZQ

K881174 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "RID PLATE READER". The FDA issued a decision of Substantially Equivalent on June 8, 1988. The device falls under product code JZQ (Plates And Equipment, Radial Immunodiffusion), a Class I device regulated under 21 CFR 866.4800. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1988
Date Received
March 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plates And Equipment, Radial Immunodiffusion
Device Class
Class I
Regulation Number
866.4800
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 JZQ

  • K881675 — IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS (April 21, 1988)
  • K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE (July 28, 1983)
  • K792699 — OUCHTERLONY AGAR PLATES (January 24, 1980)
  • K790646 — HELENA QUIPLATE SYSTEM (May 23, 1979)
  • K770548 — IMMUNOPLATE III RADIO IMMUNODIFFUSION (April 15, 1977)
  • K761311 — ACCRAASSAY RID KITS (December 30, 1976)

FDA data resources