Medical Device Manufacturer · US , Mchenry , IL

Amico Lab, Inc. - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 1982

32

Total

32

Cleared

0

Denied

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

13 devices

1-12 of 13

Cleared Dec 12, 1985

ANTI-EPSTEIN-BARR VIRUS KIT

Immunology · 520d

Cleared Dec 06, 1985

AMIZYME-CMV KIT

Immunology · 526d

Cleared Dec 06, 1985

AMIZYME-EBV TEST KIT

Immunology · 526d

Cleared Dec 06, 1985

AMIZYME-HSV TYPES 1 & 2 TEST KITS

Immunology · 526d

Cleared Dec 06, 1985

ANTI-CYTOMEGALOVIRUS KIT

Immunology · 514d

Cleared Dec 06, 1985

ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2

Immunology · 514d

Cleared Oct 30, 1984

ANTI-SCHISTOSOMA SPECIES KIT

Immunology · 112d

Cleared Oct 01, 1984

AMIZYME-C TRACHOMATIS TEST KIT

Immunology · 95d

Cleared Oct 01, 1984

ANTI-CHLAMYDIA TRACHOMATIS KIT

Immunology · 83d

Cleared Sep 20, 1984

AMIZYME-ANA TEST KIT

Immunology · 84d

Cleared Sep 20, 1984

AMIZYME-ANDNA TEST KIT

Immunology · 84d

Cleared Aug 28, 1984

AMIZYME-LEISHMANIA SPP. TEST KIT

Immunology · 61d