FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PTH RIA 200
K Number: K791128
·
Decision Sep 27, 1979
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
2
Review Days
101
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Basic Information
- Device Name
- PTH RIA 200
- K Number
- K791128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Institut National Des Radioelements
- Date Received
- June 18, 1979
- Decision Date
- September 27, 1979
- Product Code
- CEW
- 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Institut National Des Radioelements
| K Number | Device Name | ||
|---|---|---|---|
| K842267 | C-PEP-RIA-100 | Sep 6, 1984 | Substantially Equivalent |