The Binding Site, Ltd. - FDA 510(k) Cleared Devices
115
Total
115
Cleared
0
Denied
108 devices
Cleared
Dec 21, 1999
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
Immunology
57d
Cleared
Dec 21, 1999
BINDAZYME ANTI-DSDNA EIA KIT
Immunology
57d
Cleared
Dec 20, 1999
C3 MININEPH ANTISERUM
Immunology
579d
Cleared
Dec 20, 1999
C4 MININEPH ANTISERUM
Immunology
579d
Cleared
Dec 20, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
Immunology
567d
Cleared
Dec 20, 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
Immunology
553d
Cleared
Nov 26, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
Immunology
543d
Cleared
Nov 24, 1999
IGA MININEPH ANTISERUM
Immunology
553d
Cleared
Sep 17, 1999
TOTAL HAEMOLYTIC COMPLEMENT RID KIT
Immunology
53d
Cleared
Feb 23, 1999
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
Immunology
56d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
Immunology
107d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
Immunology
107d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
Immunology
107d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
Immunology
107d
Cleared
Feb 02, 1999
ANTI-TPO EIA DIAGNOSTIC TEST KIT
Immunology
74d
Cleared
Feb 02, 1999
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
Immunology
74d
Cleared
Dec 04, 1998
HUMAN IGA SUBCLASS BNII COMBI KIT
Immunology
186d
Cleared
Oct 22, 1998
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
Immunology
203d
Cleared
Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG
Immunology
118d
Cleared
Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
Immunology
118d
Cleared
Jul 20, 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
Immunology
123d
Cleared
Jul 20, 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
Immunology
123d
Cleared
Sep 29, 1997
RETINOL BINDING PROTEIN RBP RID KIT
Immunology
35d
Cleared
May 21, 1997
ANCA COMBI DIAGNOSTIC TEST KIT
Immunology
149d
Cleared
Apr 23, 1996
RIT LIVER, KIDNEY, STOMACH IFA KIT
Immunology
147d
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