FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA TSH IN HUMAN SERUM OR PLASMA
K Number: K781150
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
3
Review Days
17
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Basic Information
- Device Name
- RIA TSH IN HUMAN SERUM OR PLASMA
- K Number
- K781150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Corp. of America
- Date Received
- July 10, 1978
- Decision Date
- July 27, 1978
- Product Code
- JLW
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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