Freelite Human Kappa and Lambda Free Kits for Use on the Spaplus Analyzer

• • Terminated Z-1053-2017 FDA Class II ·initiated 28 Oct 2016 ·via K062372, on the same 510(k)

  A change in the calibration curve causing an increase in false prozone flags.

• • Terminated Z-1050-2017 FDA Class II ·initiated 28 Nov 2012 ·via K062372, on the same 510(k)

  Calibration curve activity has increased over time in the kit lots listed.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K062372 ↗

FDA Product Code

DFH

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Alpha-1-Antitrypsin Immunological Nl Test Kit

  Class II

  FDA 510(k) K913666 Active Cleared 9 Dec 1991

• Anti-Tpo Eia Diagnostic Test Kit

  Class II

  FDA 510(k) K984163 Active Cleared 2 Feb 1999

• Ena Screening Cie Kit for Diagnostic Use

  Class II

  FDA 510(k) K924262 Active Cleared 29 Dec 1992

• Iga Minineph Antiserum

  Class II

  FDA 510(k) K981786 Active Cleared 24 Nov 1999

• Anticardiolipin Iga Screen Eia Diagnostic Test Kit

  Class II

  FDA 510(k) K983696 Active Cleared 5 Feb 1999

• Human Protein S Rid Test Kit

  Class II

  FDA 510(k) K951640 Active Cleared 21 Apr 1997

See all devices from The Binding Site, Ltd. →