FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSH RIASSAY
K Number: K801691
·
Decision Aug 27, 1980
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
7
Review Days
35
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Basic Information
- Device Name
- TSH RIASSAY
- K Number
- K801691
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ria Diagnostics
- Date Received
- July 23, 1980
- Decision Date
- August 27, 1980
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Ria Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K855033 | T-3 UPTAKE/RIASSAY | Jan 24, 1986 | Substantially Equivalent |
| K854798 | T-4 RIASSAY | Jan 15, 1986 | Substantially Equivalent |
| K852537 | T-3 RIASSAY | Aug 12, 1985 | Substantially Equivalent |
| K810296 | DIGOXIN RIA ASSAY | Feb 19, 1981 | Substantially Equivalent |
| K792062 | THEOPHYLLINE RIASSAY | Feb 25, 1980 | Substantially Equivalent |
| K780012 | ANTITHROMBIN III RIA | Jan 20, 1978 | Substantially Equivalent |