Home / 510(k) Clearances / K113349

510(k) K113349

HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO by The Binding Site Group , Ltd. — Product Code DAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2012
Date Received
November 14, 2011
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 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 DAE

  • K150412 — Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (August 28, 2015)
  • K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT (September 17, 1999)
  • 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)