Nichols Institute - FDA 510(k) Cleared Devices
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nichols Institute Chemistry ✕
9 devices
Cleared
Jul 03, 1995
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)
Chemistry
33d
Cleared
Jun 23, 1995
IGFBP-3
Chemistry
183d
Cleared
May 15, 1995
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
Chemistry
105d
Cleared
Sep 08, 1993
CHEMILUMINESCENCE FREE T3 IMMUNOASSAY
Chemistry
160d
Cleared
Jul 27, 1993
ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT
Chemistry
218d
Cleared
Jul 27, 1993
CHEMILUMINESCENCE DHEA-S IMMUNOASSAY
Chemistry
117d
Cleared
Nov 18, 1992
TSH - THIRD GENERATION LOW CONTROLS
Chemistry
63d
Cleared
Jul 10, 1992
CORTISOL CHEMILUMINESCENCE ASSAY
Chemistry
36d
Cleared
Oct 12, 1990
ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM
Chemistry
77d