Orgentec - FDA 510(k) Cleared Devices
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orgentec Immunology ✕
9 devices
Cleared
May 08, 1996
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
Immunology
201d
Cleared
May 08, 1996
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
Immunology
201d
Cleared
Apr 18, 1996
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
Immunology
182d
Cleared
Apr 18, 1996
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
Immunology
182d
Cleared
Apr 18, 1996
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
Immunology
181d
Cleared
Apr 18, 1996
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
Immunology
181d
Cleared
Mar 20, 1996
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
Immunology
132d
Cleared
Mar 20, 1996
ORGENTEC ENASCREEN ELISA ASSAY
Immunology
132d
Cleared
Nov 09, 1995
ORGEN TEC ANTI-DSDNA ELISA ASSAY
Immunology
94d