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510(k) K992488

TOTAL HAEMOLYTIC COMPLEMENT RID KIT by The Binding Site, Ltd. — Product Code DAE

K992488 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "TOTAL HAEMOLYTIC COMPLEMENT RID KIT". The FDA issued a decision of Substantially Equivalent on September 17, 1999. The device falls under product code DAE (Complement C9, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1999
Date Received
July 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C9, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
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 DAE

  • K150412 — Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (August 28, 2015)
  • K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR US (July 11, 2012)
  • K974111 — QUIDEL CH50 EQ EIA (July 29, 1998)
  • K954145 — WAKO AUTOKIT CH50 (December 18, 1995)
  • K951639 — COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (October 13, 1995)

FDA data resources