Nichols Institute Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: NICHOLS ADVANTAGE ALDOSTERONE ASSAY, NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY, NICHOLS ADVANTAGE CORTISOL
68
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nichols Institute Diagnostics Immunology ✕
14 devices
Cleared
Oct 20, 2000
NICHOLS ADVANTAGE THYROGLOB
Immunology
35d
Cleared
May 09, 2000
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
Immunology
153d
Cleared
Dec 06, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY,...
Immunology
160d
Cleared
Feb 02, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
Immunology
71d
Cleared
Jan 26, 1999
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
Immunology
78d
Cleared
Oct 16, 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES...
Immunology
63d
Cleared
Apr 03, 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
Immunology
86d
Cleared
Dec 23, 1992
NICHOLS APO B CHEMILUMINESCENCE ASSAY
Immunology
41d
Cleared
Dec 02, 1987
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
Immunology
27d
Cleared
Mar 28, 1986
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
Immunology
21d
Cleared
Apr 28, 1978
AMINOGLYCOSIDE TEST SYSTEM
Immunology
172d
Cleared
Jan 20, 1978
AMINOGLYCOSIDE TEST SYSTEM
Immunology
11d
Cleared
Oct 14, 1977
PTH RIA
Immunology
21d
Cleared
May 26, 1977
LUTEINIZING HORMONE RIA REAGENT, LH-RIA
Immunology
17d