Orgentec is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orgentec - FDA 510(k) Cleared Devices
10
Total
10
Cleared
0
Denied
Orgentec has 10 FDA 510(k) cleared immunology devices. Based in Windham, US.
Historical record: 10 cleared submissions from 1995 to 1996.
Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Orgentec
10 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 29, 1996
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
Chemistry
70d
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