Nichols Institute Diagnostics - FDA 510(k) Cleared Devices
68
Total
68
Cleared
0
Denied
68 devices
Cleared
Mar 18, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
Chemistry
270d
Cleared
Mar 11, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
Chemistry
83d
Cleared
Feb 18, 1997
STRATEC LIA II ANALYZER
Hematology
334d
Cleared
Dec 24, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
Chemistry
175d
Cleared
Dec 10, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
Chemistry
161d
Cleared
Sep 27, 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
Chemistry
126d
Cleared
Jul 16, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD...
Chemistry
77d
Cleared
Jul 08, 1996
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
Chemistry
68d
Cleared
Nov 20, 1995
CALCITONIN IMMUNOASSAY KIT
Chemistry
348d
Cleared
Nov 03, 1995
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
Chemistry
42d
Cleared
Aug 02, 1995
5STRATEC SL 300 LIA-MAT
Chemistry
210d
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
Dec 23, 1992
NICHOLS APO B CHEMILUMINESCENCE ASSAY
Immunology
41d
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
Dec 02, 1987
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
Immunology
27d
Cleared
Sep 02, 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
Chemistry
75d
Cleared
Oct 16, 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
Chemistry
27d