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510(k) K955431

RIT LIVER, KIDNEY, STOMACH IFA KIT by The Binding Site, Ltd. — Product Code DBL

K955431 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "RIT LIVER, KIDNEY, STOMACH IFA KIT". The FDA issued a decision of Substantially Equivalent on April 23, 1996. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
November 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
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 DBL

  • K180202 — Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immun (October 19, 2018)
  • K980312 — NOVA LITE ENDOMYSIAL (April 2, 1998)
  • K974169 — WIELISA ANTI-GBM TEST SYSTEM (February 17, 1998)
  • K971464 — IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (October 29, 1997)
  • K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (May 23, 1997)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K953495 — EIA KIT FOR THE DETECTION OF GBM ANTIBODIES (April 10, 1996)
  • K944191 — ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (March 6, 1995)
  • K944192 — ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (March 6, 1995)
  • K913360 — ANTI-RETICULIN ANTIBODY (ARA) TEST (September 26, 1994)

FDA data resources