FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K964260 |
BECKMAN INSTRUMENTS, INC. |
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG |
02/10/1997 |
K153394 |
Diazyme Laboratories |
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator |
11/18/2016 |
K211648 |
Diazyme Laboratories Inc. |
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay |
09/08/2022 |
K220001 |
Diazyme Laboratories Inc. |
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay |
08/04/2022 |
K181438 |
Diazyme Laboratories Inc. |
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay |
06/26/2018 |
K210623 |
Sebia |
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 |
11/18/2022 |
K042939 |
Sebia, Inc. |
CAPILLARY'S IMMUNOTYPING (PN 2100) |
06/27/2005 |
K083602 |
SENTINEL CH. SpA |
KAPPA LIGHT CHAINS |
09/03/2009 |
K082503 |
SIEMENS HEALTHCARE DIAGNOSTICS |
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL |
12/19/2008 |
K182098 |
Siemens Healthcare Diagnostics Products GmbH |
N Latex FLC kappa assay, N Latex FLC lambda assay |
11/01/2018 |
K171742 |
Siemens Healthcare Diagnostics Products GmbH |
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 |
11/17/2017 |
K190879 |
Siemens Healthcare Diagnostics Products GmbH |
N Latex FLC kappa, N Latex FLC lambda |
05/03/2019 |
K212379 |
Siemens Healthcare Diagnostics Products GmbH |
N Latex FLC kappa, N Latex FLC lambda |
03/02/2022 |
K193047 |
Siemens Healthcare Diagnostics Products GmbH |
N Latex FLC kappa, N Latex FLC lambda |
07/14/2021 |
K201496 |
Siemens Healthcare Diagnostics Products GmbH |
N Latex FLC kappa, N Latex FLC lambda |
10/29/2021 |
K120056 |
THE BINDING SITE GROUP LTD |
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER |
04/01/2013 |
K150658 |
THE BINDING SITE GROUP LTD |
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit |
08/26/2015 |
K173732 |
The Binding Site Group Ltd |
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit |
08/23/2018 |
K023009 |
THE BINDING SITE, LTD. |
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER |
01/21/2003 |
K070900 |
THE BINDING SITE, LTD. |
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT |
11/30/2007 |
K062372 |
THE BINDING SITE, LTD. |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER |
06/21/2007 |
K051915 |
THE BINDING SITE, LTD. |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER |
09/06/2005 |
K040009 |
THE BINDING SITE, LTD. |
FREELITE HUMAN KAPPA AND LAMBDA KITS |
03/11/2004 |
K003669 |
THE BINDING SITE, LTD. |
KAPPA IMMAGE FREELITE KIT |
02/01/2001 |
K002564 |
THE BINDING SITE, LTD. |
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT |
10/26/2000 |