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510(k) K915431

COMPLEMENT C1 INACTIVATOR KIT by The Binding Site, Ltd. — Product Code DBA

K915431 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "COMPLEMENT C1 INACTIVATOR KIT". The FDA issued a decision of Substantially Equivalent on January 17, 1992. The device falls under product code DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5250. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1992
Date Received
December 2, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5250
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 DBA

  • K141100 — OPTILITE C1 INACTIVATOR KIT (July 18, 2014)
  • K122304 — HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (April 15, 2013)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)
  • K011780 — K-ASSAY C1-INA (July 25, 2001)
  • K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE (March 19, 2001)
  • K965024 — N-ASSAY TIA C1-INACTIVATOR TEST KIT (July 14, 1997)
  • K960257 — N ANTISERUM TO C1 INHIBITOR (August 1, 1996)
  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K872426 — CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (July 23, 1987)
  • K821898 — ORTHO CLASSICAL PATHWAY COMPL. TEST (July 16, 1982)

FDA data resources