Medical Device Manufacturer · US , Mchenry , IL

Diagnostica, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1978

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diagnostica, Inc. Immunology ✕

7 devices

1-7 of 7

Cleared Dec 28, 1982

H. INFLUENZA B ANTISERA FOR CIE

Immunology · 49d

Cleared Mar 12, 1980

PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT

Immunology · 15d

Cleared Nov 27, 1979

ANTI-HUMAN IGG SERUM

Immunology · 140d

Cleared Nov 27, 1979

ANTI-HUMAN LAMBDA SERUM

Immunology · 140d

Cleared Nov 27, 1979

ANTI-HUMAN KAPPA SERUM

Immunology · 140d

Cleared Oct 17, 1979

ANTI-HUMAN SERUM

Immunology · 99d

Cleared Oct 17, 1979

ANTI-HUMAN GLOBULINS

Immunology · 99d