FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
K Number: K896222
·
Decision Nov 17, 1989
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
68
Review Days
18
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
- K Number
- K896222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nichols Institute Diagnostics
- Date Received
- October 30, 1989
- Decision Date
- November 17, 1989
- Product Code
- CEC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEC), ordered by most recent decision date.
Access Free T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys FT4 IV
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAGLUMI 2000 FT4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys FT4 III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Abbott Architect Free T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREND Free T4 Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |