Nichols Institute Diagnostics - FDA 510(k) Cleared Devices
68
Total
68
Cleared
0
Denied
50 devices
Cleared
May 02, 1995
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY
Chemistry
62d
Cleared
Apr 05, 1995
CHEMILUMINESCENCE LH
Chemistry
532d
Cleared
Nov 17, 1993
T3 UPTAKE CHEMILUMINESCENCE ASSAY
Chemistry
342d
Cleared
Jan 06, 1993
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
Chemistry
40d
Cleared
Sep 02, 1992
TOTAL T3 CHEMILUMINESCENCE ASSAY
Chemistry
72d
Cleared
Jan 19, 1990
IGF-I BY EXTRACTION
Chemistry
46d
Cleared
Nov 17, 1989
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
Chemistry
18d
Cleared
Aug 30, 1988
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
Chemistry
60d
Cleared
Apr 28, 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
Chemistry
43d
Cleared
Apr 18, 1988
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
Chemistry
33d
Cleared
Sep 02, 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
Chemistry
75d
Cleared
Oct 16, 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
Chemistry
27d
Cleared
Oct 16, 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
Chemistry
27d
Cleared
Jul 22, 1986
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
Chemistry
74d
Cleared
Jan 28, 1986
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
Chemistry
57d
Cleared
Oct 02, 1985
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM
Chemistry
27d
Cleared
May 13, 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
Chemistry
46d
Cleared
Oct 22, 1984
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
Chemistry
223d
Cleared
Oct 11, 1984
C-TERMINAL/MID-MOLECULE PARATHYROID -
Chemistry
23d
Cleared
Sep 05, 1984
CALCITONIN RADIOIMMUNOASSAY KIT
Chemistry
43d
Cleared
Jun 25, 1984
THYROXINE-BINDING GLOBULIN RADIOUMMU
Chemistry
39d
Cleared
Apr 04, 1984
PARATHYROID HORMONE ANALYSIS PRODUCT
Chemistry
68d
Cleared
Jan 11, 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
Chemistry
97d
Cleared
Jan 10, 1979
HORMONE KIT, PARATHYROID
Chemistry
40d
Cleared
Oct 18, 1977
FOLLICLE-STIMULATING HORMONE
Chemistry
32d