Medical Device Manufacturer · US , Mchenry , IL

Nichols Institute Diagnostics

68 submissions · 68 cleared · Since 1977
68
Total
68
Cleared
0
Denied

Nichols Institute Diagnostics — FDA 510(k) Submissions

Nichols Institute Diagnostics has submitted 68 FDA 510(k) premarket notifications since 1977, of which 68 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Parathyroid Hormone, Radioimmunoassay, Luteinizing Hormone, Radioimmunoassay, Human Growth Hormone, Radioimmunoassay, Follicle-stimulating Hormone, Radioimmunoassay, Acth . Use the specialty filter in the sidebar to narrow results.

68 devices
1–12 of 68
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · CJM Radioimmunoassay,... · Chemistry
Jun 2005 65d
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
K042676 · DHA System, Test, Human... · Chemistry
Dec 2004 79d
NICHOLS ADVANTAGE CORTISOL
K042689 · CGR Radioimmunoassay, Cortisol · Chemistry
Dec 2004 71d
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
K040813 · CEW Radioimmunoassay,... · Chemistry
Jun 2004 70d
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
K033727 · CEW Radioimmunoassay,... · Chemistry
Apr 2004 146d
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302 · CEW Radioimmunoassay,... · Chemistry
Jan 2004 104d
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K032188 · CJM Radioimmunoassay,... · Chemistry
Jul 2003 14d
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356 · LYR Helicobacter Pylori · Microbiology
Oct 2002 98d
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
K022472 · CEW Radioimmunoassay,... · Chemistry
Oct 2002 75d
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
K013992 · CEW Radioimmunoassay,... · Chemistry
Dec 2001 9d
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
K012367 · JIT Calibrator, Secondary · Chemistry
Oct 2001 75d
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
K011128 · CIB Radioimmunoassay,... · Chemistry
Sep 2001 146d

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