FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
K Number: K982866
·
Decision Oct 16, 1998
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
68
Review Days
63
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Basic Information
- Device Name
- NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
- K Number
- K982866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nichols Institute Diagnostics
- Date Received
- August 14, 1998
- Decision Date
- October 16, 1998
- Product Code
- JZO
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | FDA class 2 | Immunology |
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Other Clearances by Nichols Institute Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Jun 1, 2005 | Substantially Equivalent |
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY | Dec 17, 2004 | Substantially Equivalent |
| K042689 | NICHOLS ADVANTAGE CORTISOL | Dec 9, 2004 | Substantially Equivalent |
| K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 | Jun 8, 2004 | Substantially Equivalent |
| K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY | Apr 22, 2004 | Substantially Equivalent |
| K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 | Jan 26, 2004 | Substantially Equivalent |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Jul 31, 2003 | Substantially Equivalent |
| K022356 | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY | Oct 25, 2002 | Substantially Equivalent |
| K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) | Oct 9, 2002 | Substantially Equivalent |
| K013992 | NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY | Dec 13, 2001 | Substantially Equivalent |