FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSH (RIA) KIT
K Number: K820089
·
Decision Jan 28, 1982
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
10
Review Days
15
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Basic Information
- Device Name
- TSH (RIA) KIT
- K Number
- K820089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuno Assay Corp.
- Date Received
- January 13, 1982
- Decision Date
- January 28, 1982
- 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 Immuno Assay Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833842 | RIA COAT DIGOXIN | Jan 17, 1984 | Substantially Equivalent |
| K833745 | RIACOAT T-4 | Jan 4, 1984 | Substantially Equivalent |
| K820074 | CORTISOL (RIA) KIT | Jan 28, 1982 | Substantially Equivalent |
| K811954 | COMBO-FER IRON DIAGNOSTIC | Jul 27, 1981 | Substantially Equivalent |
| K811725 | TBG DIAGNOSTIC KIT | Jul 10, 1981 | Substantially Equivalent |
| K811213 | T3 (RIA) KIT | May 29, 1981 | Substantially Equivalent |
| K811212 | DIGOXIN (RIA) KIT | May 21, 1981 | Substantially Equivalent |
| K810857 | T3 UPTAKE KIT | Apr 8, 1981 | Substantially Equivalent |
| K810811 | T4 RIA KIT | Apr 7, 1981 | Substantially Equivalent |