Home / 510(k) Clearances / K122965

510(k) K122965

HUMAN CAERULOPLASMIN KIT by The Binding Site Group , Ltd. — Product Code DDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2013
Date Received
September 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ceruloplasmin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5210
Review Panel
IM
Submission Type

Other clearances by The Binding Site Group , Ltd.

  • K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (October 17, 2025)
  • K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (May 23, 2025)
  • K192116 — Human IgA liquid reagent kit for Use on SPAPlus (September 4, 2019)
  • K191985 — Optilite IgA Kit (August 19, 2019)
  • K191635 — Optilite IgM Kit (July 15, 2019)
  • K191465 — Human IgM Kit for use on SPAPlus (June 27, 2019)
  • K190686 — Optilite IgM CSF Kit (May 28, 2019)
  • K183151 — Optilite IgA CSF Kit (January 23, 2019)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K173732 — Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (August 23, 2018)

Other clearances for product code DDB

  • K161508 — Ceruloplasmin (January 9, 2017)
  • K053074 — N ANTISERA TO HUMAN CERULOPLASMIN (March 16, 2006)
  • K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT (April 25, 1997)
  • K913668 — CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (December 20, 1991)
  • K895377 — QM300 CERULOPLASMIN ANTIBODY PACK (September 21, 1989)
  • K860138 — NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM (March 28, 1986)
  • K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
  • K852247 — LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) (July 10, 1985)
  • K851283 — RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN (May 23, 1985)
  • K823107 — QUANTIMETRIC 2 CERULOPLASMIN ASSAY (November 16, 1982)