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510(k) K922416

FIBRINOGEN RID TEST KIT by The Binding Site, Ltd. — Product Code KQJ

K922416 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "FIBRINOGEN RID TEST KIT". The FDA issued a decision of Substantially Equivalent on March 9, 1993. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1993
Date Received
May 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Fibrinogen Determination
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
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 KQJ

  • K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (July 24, 2025)
  • K073367 — HEMOSIL FIBRINOGEN-C (December 27, 2007)
  • K050928 — DADE THROMBIN REAGENT (June 29, 2005)
  • K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) (October 9, 1997)
  • K970189 — FIF TM (May 21, 1997)
  • K965113 — N-ASSAY TIA FIBRINOGEN TEST KIT (April 16, 1997)
  • K934326 — MULTIFIBREN U (April 19, 1994)
  • K931721 — IL TEST FIBRINOGEN-C (August 13, 1993)
  • K925988 — MULTIFIBREN (March 1, 1993)
  • K923593 — HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS (September 22, 1992)

FDA data resources