Home / 510(k) Clearances / K881828

510(k) K881828

IMMUNOGLOBULIN M TEST SYSTEM by The Binding Site, Ltd. — Product Code CFQ

K881828 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "IMMUNOGLOBULIN M TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 6, 1988. The device falls under product code CFQ (Radioimmunoassay, Immunoglobulins (G, A, M)), 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
June 6, 1988
Date Received
April 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoglobulins (G, A, M)
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 CFQ

  • K981786 — IGA MININEPH ANTISERUM (November 24, 1999)
  • K990552 — IMMUNOGLOBULIN A TEST SYSTEM (March 25, 1999)
  • K990551 — IGG FLEX REAGENT CARTRIDGE (March 25, 1999)
  • K990553 — IGM FLEX REAGENT CARTRIDGE (March 22, 1999)
  • K951055 — OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT (April 17, 1995)
  • K951013 — OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT (April 17, 1995)
  • K950900 — OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT (March 27, 1995)
  • K891188 — TITAN GEL IFE TRIVALENT ANTISERUM (March 22, 1989)
  • K890561 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (February 23, 1989)
  • K881928 — MONOCLONAL RADIAL IMMUNODIFFUSION KIT (July 8, 1988)

FDA data resources