FDA 510(k) Applications Submitted by JAY H GELLER

FDA 510(k) Number Submission Date Device Name Applicant
K100179 01/21/2010 SPAPLUS THE BINDING SITE GROUP, LTD.
K100455 02/17/2010 SPAPLUS ANALYZER THE BINDING SITE
K100588 03/02/2010 HUMAN IGA2 KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD
K981929 05/08/1998 BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT THE BINDING SITE, LTD.
K953207 05/30/1995 HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) THE BINDING SITE, LTD.
K922900 06/16/1992 INFRARED LAMP HARRIER, INC.
K894209 06/19/1989 ENEMA KIT LEDINS HERBAL HEALING SYSTEMS
K012291 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA THE BINDING SITE, LTD.
K072166 08/06/2007 CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER THE BINDING SITE
K913540 08/09/1991 PEDIA-THOR THORACOSTOMY KIT INTL. MEDICAL DEVICES LTD.
K913542 08/09/1991 THORACIC CATHETER WITH GUIDE INTL. MEDICAL DEVICES LTD.
K913543 08/09/1991 THORACIC CATHETER STYLET INTL. MEDICAL DEVICES LTD.
K092450 08/10/2009 HUMAN IGD KIT FOR USE ON SPAPLUS THE BINDING SITE
K915431 12/02/1991 COMPLEMENT C1 INACTIVATOR KIT THE BINDING SITE, LTD.
K905633 12/14/1990 HUMAN C-REACTIVE PROTEIN RID KIT THE BINDING SITE, LTD.
K040009 01/02/2004 FREELITE HUMAN KAPPA AND LAMBDA KITS THE BINDING SITE, LTD.
K950015 01/03/1995 HUMAN PROTEIN C RID TEST KIT JAY H. GELLER
K920087 01/08/1992 IGE EIA TEST KIT 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.
K930247 01/19/1993 HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE THE BINDING SITE, LTD.
K940422 01/19/1994 IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER THE BINDING SITE, LTD.
K030238 01/23/2003 BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT THE BINDING SITE, LTD.
K850398 02/01/1985 NU-CATH EMERGENCY KIT INTL. MEDICAL DEVICES 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.
K890852 02/21/1989 AQUA-BLANKET HYPER/HYPOHERMIA BLANKET ATI
K890853 02/21/1989 AQUA-PAD FOR MOIST OR DRY HEAT THERAPY ATI
K040466 02/23/2004 BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS THE BINDING SITE
K930987 02/25/1993 CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) THE BINDING SITE, LTD.
K000701 03/01/2000 HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER THE BINDING SITE, LTD.
K881046 03/11/1988 SUPER PIK MASSAGING PICK FOR ORAL HYGIENE U.S. DENTEK CORP.
K881174 03/18/1988 RID PLATE READER 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.
K941346 03/21/1994 PLASMINOGEN RID TEST 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.
K851409 04/09/1985 UNILOC TOTAL HIP PROSTHESIS SERRANO INTL.
K951640 04/10/1995 HUMAN PROTEIN S RID TEST KIT THE BINDING SITE, LTD.
K931806 04/12/1993 IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE THE BINDING SITE, LTD.
K971658 04/14/1997 MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT JAY H. GELLER
K881827 04/29/1988 IMMUNOGLOBULIN A TEST SYSTEM THE BINDING SITE, LTD.
K881828 04/29/1988 IMMUNOGLOBULIN M TEST SYSTEM THE BINDING SITE, LTD.
K952069 05/02/1995 MECHANICAL WHEELCHAIR GRAND SEATING KING CORP.
K981644 05/08/1998 BINDAZYME ANTIGLIADIN IGG THE BINDING SITE, LTD.
K881928 05/09/1988 MONOCLONAL RADIAL IMMUNODIFFUSION KIT THE BINDING SITE, LTD.
K942326 05/13/1994 HUMAN C5 RID KITS JAY H. GELLER
K893899 05/15/1989 STERILE LATEX SURGICAL GLOVES LIFE FORCE LABORATORIES, INC.
K001556 05/18/2000 HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY THE BINDING SITE, LTD.
K051299 05/18/2005 IGD DIAGNOSTIC TEST KITS 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.
K981784 05/20/1998 IGM 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.
K922416 05/21/1992 FIBRINOGEN RID TEST KIT THE BINDING SITE, LTD.
K922417 05/21/1992 AL-ACID GLYCOPROTEIN RID KIT 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.
K862031 05/28/1986 HAWKINS MINI-E.B.A. PB SALES C/O GELLER & BOZEMAN
K011662 05/29/2001 MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL THE BINDING SITE, LTD.
K011663 05/29/2001 MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS THE BINDING SITE, LTD.
K902382 05/30/1990 C3C AND C4 RID KITS THE BINDING SITE, LTD.
K001636 05/30/2000 C-REACTIVE PROTEIN ANTISERUM KIT THE BINDING SITE, LTD.
K981912 06/01/1998 HUMAN IGA SUBCLASS BNII COMBI KIT THE BINDING SITE, LTD.
K981914 06/01/1998 TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION THE BINDING SITE, LTD.
K981915 06/01/1998 TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION THE BINDING SITE, LTD.
K962287 06/14/1996 EAGLE EYES SUNGLASSES POSITIVE RESPONSE TELEVISION
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.
K001859 06/19/2000 PENILE CONSTRICTOR RING BASIC SOLUTIONS, LLC.
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.
K943334 07/12/1994 HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT JAY H. GELLER
K041891 07/12/2004 MININEPH HUMAN RHEUMATOID FACTOR KIT THE BINDING SITE
K051915 07/15/2005 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER THE BINDING SITE, LTD.
K012292 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB THE BINDING SITE, LTD.
K012295 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T THE BINDING SITE, LTD.
K012296 07/20/2001 HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T 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.
K913539 08/09/1991 THORACIC CATHTER STYLET INTL. MEDICAL DEVICES LTD.
K913541 08/09/1991 NEO-THOR THORACOSTOMY KIT INTL. MEDICAL DEVICES LTD.
K042152 08/09/2004 BINDING SITE IGG SUBLCASS OLYMPUS KITS THE BINDING SITE
K924021 08/11/1992 POWER SUPPLY THE BINDING SITE, LTD.
K924020 08/11/1992 ELECTROPHORESIS TANK THE BINDING SITE, LTD.
K854191 08/12/1985 MECRON UNCEMENTED STRUCTURED STEM HIP MECRON MEDICAL PRODUCTS, INC.
K062372 08/14/2006 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER THE BINDING SITE, LTD.
K933965 08/16/1993 APEX MEDICAL AIR PUMPS APEX MEDICAL, INC.
K002560 08/17/2000 SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT THE BINDING SITE, LTD.
K002561 08/17/2000 SHEEP ANTI-HUMAN IGD 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.
K002564 08/17/2000 SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT THE BINDING SITE, LTD.
K913666 08/19/1991 ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT THE BINDING SITE, LTD.
K913667 08/19/1991 ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT THE BINDING SITE, LTD.
K913668 08/19/1991 CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT THE BINDING SITE, LTD.
K913670 08/19/1991 HAPTOGLOBIN IMMUNOLOGICAL TEST KIT THE BINDING SITE, LTD.
K913671 08/19/1991 HUMAN IGD IMMUNOLOGICAL NL TEST KIT THE BINDING SITE, LTD.
K913672 08/19/1991 PREALBUMIN IMMUNOLOGICAL NL TEST KIT THE BINDING SITE, LTD.
K924262 08/24/1992 ENA SCREENING CIE KIT FOR DIAGNOSTIC USE THE BINDING SITE, LTD.
K925118 08/24/1992 EN TYPING CIE KIT FOR DIAGNOSTIC USE THE BINDING SITE, LTD.
K973189 08/25/1997 RETINOL BINDING PROTEIN RBP RID 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.
K023131 09/09/2002 FREELITE HUMAN LAMBDA FREE KIT THE BINDING SITE, LTD.
K895600 09/18/1989 HUMAN (IGG) SUBCLASS (EIA) KIT THE BINDING SITE, LTD.
K042579 09/22/2004 BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT THE BINDING SITE
K924767 09/23/1992 IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC THE BINDING SITE, LTD.
K924769 09/23/1992 IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC THE BINDING SITE, LTD.
K082823 09/25/2008 HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS THE BINDING SITE GROUP LTD
K914388 10/01/1991 C1 RID KIT THE BINDING SITE, LTD.
K914389 10/01/1991 ALPHA-2 MACROGLOBULIN TEST RID KIT THE BINDING SITE, LTD.
K914390 10/01/1991 TRANSFERRIN RID KIT THE BINDING SITE, LTD.
K914391 10/01/1991 ALBUMIN TEST RID KIT THE BINDING SITE, LTD.
K072889 10/10/2007 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER THE BINDING SITE, LTD.
K983695 10/21/1998 ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD.
K983696 10/21/1998 ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD.
K983692 10/21/1998 ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST THE BINDING SITE, LTD.
K983694 10/21/1998 ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD.
K993612 10/25/1999 BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA THE BINDING SITE, LTD.
K993727 10/25/1999 BINDAZYME ANTI-DSDNA EIA KIT THE BINDING SITE, LTD.
K083289 11/07/2008 HUMAN BETA-2 MICROGLOBULIN KIT THE BINDING SITE, LTD.
K844486 11/19/1984 MECRON MRC-HEADLESS FEMORAL COMPONENT MECRON MEDICAL PRODUCTS, INC.
K844487 11/19/1984 MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR MECRON MEDICAL PRODUCTS, INC.
K844488 11/19/1984 MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS MECRON MEDICAL PRODUCTS, INC.
K844489 11/19/1984 ELECTRONIC MUSCLE STIMULATOR BEVERLY HILLS EXERCISE EQUIPMENT
K984163 11/20/1998 ANTI-TPO EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD.
K984165 11/20/1998 ANTI-THYROGLOBULIN 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.
K875356 12/31/1987 IMMUNOGLOBULIN G & G SUBCLASSES BIRMINGHAM


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