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 Chemistry ✕
50 devices
Cleared
Jun 01, 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
Chemistry
65d
Cleared
Dec 17, 2004
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
Chemistry
79d
Cleared
Dec 09, 2004
NICHOLS ADVANTAGE CORTISOL
Chemistry
71d
Cleared
Jun 08, 2004
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
Chemistry
70d
Cleared
Apr 22, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
Chemistry
146d
Cleared
Jan 26, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
Chemistry
104d
Cleared
Jul 31, 2003
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
Chemistry
14d
Cleared
Oct 09, 2002
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE...
Chemistry
75d
Cleared
Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84)...
Chemistry
9d
Cleared
Oct 09, 2001
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
Chemistry
75d
Cleared
Sep 06, 2001
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS,...
Chemistry
146d
Cleared
Feb 05, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
Chemistry
46d
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