The Binding Site, Ltd. - FDA 510(k) Cleared Devices
115
Total
115
Cleared
0
Denied
108 devices
Cleared
Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
Immunology
31d
Cleared
Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
Immunology
31d
Cleared
Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
Immunology
62d
Cleared
Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
Immunology
62d
Cleared
Apr 26, 2001
FREELITE LAMBDA FREE KIT
Immunology
72d
Cleared
Apr 26, 2001
FREELITE KAPPA FREE KIT
Immunology
72d
Cleared
Mar 01, 2001
ENA EIA KIT RANGE
Immunology
43d
Cleared
Mar 01, 2001
ENA EIA KIT
Immunology
43d
Cleared
Feb 23, 2001
ENA SCREEN EIA KIT
Immunology
37d
Cleared
Feb 15, 2001
ANA EIA DIAGNOSTIC TEST KIT
Immunology
50d
Cleared
Feb 01, 2001
KAPPA IMMAGE FREELITE KIT
Immunology
65d
Cleared
Feb 01, 2001
LAMBDA IMMAGE FREELITE KIT
Immunology
65d
Cleared
Oct 26, 2000
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
Immunology
70d
Cleared
Oct 26, 2000
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
Immunology
70d
Cleared
Oct 26, 2000
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
Immunology
70d
Cleared
Oct 26, 2000
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
Immunology
70d
Cleared
Aug 30, 2000
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
Immunology
149d
Cleared
Aug 24, 2000
C-REACTIVE PROTEIN ANTISERUM KIT
Immunology
86d
Cleared
Aug 21, 2000
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
Immunology
95d
Cleared
May 05, 2000
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
Immunology
345d
Cleared
May 05, 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
Immunology
345d
Cleared
May 05, 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
Immunology
345d
Cleared
May 05, 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
Immunology
345d
Cleared
Apr 27, 2000
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
Immunology
57d
Cleared
Dec 21, 1999
IGM MININEPH ANTISERUM
Immunology
580d
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