Home / 510(k) Clearances / K895600

510(k) K895600

HUMAN (IGG) SUBCLASS (EIA) KIT by The Binding Site, Ltd. — Product Code DAS

K895600 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "HUMAN (IGG) SUBCLASS (EIA) KIT". The FDA issued a decision of Substantially Equivalent on November 8, 1989. The device falls under product code DAS (Igg (Fc Fragment Specific), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5530. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
September 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5530
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 DAS

  • K982023 — PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (September 4, 1998)
  • K944876 — HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (December 15, 1994)
  • K943205 — HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (September 7, 1994)
  • K943098 — HUMAN IGG SUBCLASSES ELISA COMBI KIT (September 7, 1994)
  • K790708 — ANTISERUM TO HUMAN IG G FC FRAGMENTS (August 22, 1979)
  • K790715 — ANTISERUM TO HUMAN FC (August 16, 1979)
  • K761156 — AMINOGLYCOSIDE CONTROLS (December 9, 1976)

FDA data resources