FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAC-CEL PTH KIT RD51
K Number: K831069
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
28
Review Days
73
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Basic Information
- Device Name
- DAC-CEL PTH KIT RD51
- K Number
- K831069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Wellcome Diagnostics
- Date Received
- April 4, 1983
- Decision Date
- June 16, 1983
- 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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