Medical Device Manufacturer · US , Windham , NH

Orgentec - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1995

Recent clearances: ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY, ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY, ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orgentec Immunology ✕

9 devices

1-9 of 9

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