FDA 510(k) Applications Submitted by THE BINDING SITE, LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K981929 |
05/08/1998 |
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT |
THE BINDING SITE, LTD. |
| K012291 |
07/20/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA |
THE BINDING SITE, LTD. |
| K040009 |
01/02/2004 |
FREELITE HUMAN KAPPA AND LAMBDA KITS |
THE BINDING SITE, LTD. |
| K010146 |
01/17/2001 |
ENA EIA KIT RANGE |
THE BINDING SITE, LTD. |
| K010147 |
01/17/2001 |
ENA EIA KIT |
THE BINDING SITE, LTD. |
| K010148 |
01/17/2001 |
ENA SCREEN EIA KIT |
THE BINDING SITE, LTD. |
| K030238 |
01/23/2003 |
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT |
THE BINDING SITE, LTD. |
| K010440 |
02/13/2001 |
FREELITE LAMBDA FREE KIT |
THE BINDING SITE, LTD. |
| K010441 |
02/13/2001 |
FREELITE KAPPA FREE KIT |
THE BINDING SITE, LTD. |
| K080384 |
02/13/2008 |
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER |
THE BINDING SITE, LTD. |
| K000701 |
03/01/2000 |
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER |
THE BINDING SITE, LTD. |
| K981029 |
03/19/1998 |
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
| K981030 |
03/19/1998 |
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
| K031016 |
03/31/2003 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II |
THE BINDING SITE, LTD. |
| K090920 |
04/01/2009 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) |
THE BINDING SITE, LTD. |
| K981209 |
04/02/1998 |
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS |
THE BINDING SITE, LTD. |
| K070900 |
04/02/2007 |
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT |
THE BINDING SITE, LTD. |
| K001127 |
04/03/2000 |
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY |
THE BINDING SITE, LTD. |
| K021081 |
04/03/2002 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER |
THE BINDING SITE, LTD. |
| K951640 |
04/10/1995 |
HUMAN PROTEIN S RID TEST KIT |
THE BINDING SITE, LTD. |
| K981644 |
05/08/1998 |
BINDAZYME ANTIGLIADIN IGG |
THE BINDING SITE, LTD. |
| K001556 |
05/18/2000 |
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY |
THE BINDING SITE, LTD. |
| K031563 |
05/19/2003 |
BINDAZYME CLQ CIC EIA KIT |
THE BINDING SITE, LTD. |
| K981783 |
05/20/1998 |
C3 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
| K981785 |
05/20/1998 |
C4 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
| K981786 |
05/20/1998 |
IGA MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
| K981784 |
05/20/1998 |
IGM MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
| K991801 |
05/26/1999 |
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT |
THE BINDING SITE, LTD. |
| K991802 |
05/26/1999 |
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT |
THE BINDING SITE, LTD. |
| K991803 |
05/26/1999 |
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. |
THE BINDING SITE, LTD. |
| K991804 |
05/26/1999 |
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. |
THE BINDING SITE, LTD. |
| K011663 |
05/29/2001 |
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS |
THE BINDING SITE, LTD. |
| K011662 |
05/29/2001 |
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL |
THE BINDING SITE, LTD. |
| K001636 |
05/30/2000 |
C-REACTIVE PROTEIN ANTISERUM KIT |
THE BINDING SITE, LTD. |
| K981914 |
06/01/1998 |
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION |
THE BINDING SITE, LTD. |
| K981912 |
06/01/1998 |
HUMAN IGA SUBCLASS BNII COMBI KIT |
THE BINDING SITE, LTD. |
| K981915 |
06/01/1998 |
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION |
THE BINDING SITE, LTD. |
| K982100 |
06/15/1998 |
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS |
THE BINDING SITE, LTD. |
| K081674 |
06/17/2008 |
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) |
THE BINDING SITE, LTD. |
| K022083 |
06/26/2002 |
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER |
THE BINDING SITE, LTD. |
| K081827 |
06/27/2008 |
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS |
THE BINDING SITE, LTD. |
| K051915 |
07/15/2005 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER |
THE BINDING SITE, LTD. |
| K012296 |
07/20/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T |
THE BINDING SITE, LTD. |
| K012295 |
07/20/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T |
THE BINDING SITE, LTD. |
| K012292 |
07/20/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB |
THE BINDING SITE, LTD. |
| K032240 |
07/21/2003 |
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
| K992488 |
07/26/1999 |
TOTAL HAEMOLYTIC COMPLEMENT RID KIT |
THE BINDING SITE, LTD. |
| K082129 |
07/29/2008 |
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER |
THE BINDING SITE, LTD. |
| K062183 |
07/31/2006 |
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
| K062372 |
08/14/2006 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER |
THE BINDING SITE, LTD. |
| K002560 |
08/17/2000 |
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
| K002564 |
08/17/2000 |
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
| K002563 |
08/17/2000 |
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
| K002561 |
08/17/2000 |
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT |
THE BINDING SITE, LTD. |
| K973189 |
08/25/1997 |
RETINOL BINDING PROTEIN RBP RID KIT |
THE BINDING SITE, LTD. |
| K023131 |
09/09/2002 |
FREELITE HUMAN LAMBDA FREE KIT |
THE BINDING SITE, LTD. |
| K023009 |
09/09/2002 |
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER |
THE BINDING SITE, LTD. |
| K072889 |
10/10/2007 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER |
THE BINDING SITE, LTD. |
| K983696 |
10/21/1998 |
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K983695 |
10/21/1998 |
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K983694 |
10/21/1998 |
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K983692 |
10/21/1998 |
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST |
THE BINDING SITE, LTD. |
| K993727 |
10/25/1999 |
BINDAZYME ANTI-DSDNA EIA KIT |
THE BINDING SITE, LTD. |
| K993612 |
10/25/1999 |
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA |
THE BINDING SITE, LTD. |
| K083289 |
11/07/2008 |
HUMAN BETA-2 MICROGLOBULIN KIT |
THE BINDING SITE, LTD. |
| K984165 |
11/20/1998 |
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K984163 |
11/20/1998 |
ANTI-TPO EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K946069 |
11/23/1994 |
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT |
THE BINDING SITE, LTD. |
| K946070 |
11/23/1994 |
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT |
THE BINDING SITE, LTD. |
| K955431 |
11/28/1995 |
RIT LIVER, KIDNEY, STOMACH IFA KIT |
THE BINDING SITE, LTD. |
| K003669 |
11/28/2000 |
KAPPA IMMAGE FREELITE KIT |
THE BINDING SITE, LTD. |
| K003671 |
11/28/2000 |
LAMBDA IMMAGE FREELITE KIT |
THE BINDING SITE, LTD. |
| K033811 |
12/09/2003 |
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER |
THE BINDING SITE, LTD. |
| K965133 |
12/23/1996 |
ANCA COMBI DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K004019 |
12/27/2000 |
ANA EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K014270 |
12/27/2001 |
MININEPH HUMAN B2-MICROGLOBULIN KIT |
THE BINDING SITE, LTD. |
| K955881 |
12/28/1995 |
RETINOL BINDING RID KIT |
THE BINDING SITE, LTD. |
| K984619 |
12/29/1998 |
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT |
THE BINDING SITE, LTD. |
| K946068 |
11/23/1994 |
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT |
THE BINDING SITE, LTD. |
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