FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I-DHEA-SULFATE RIA KIT 125
K Number: K821145
·
Decision May 14, 1982
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
27
Applicant Total
5
Review Days
23
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Basic Information
- Device Name
- I-DHEA-SULFATE RIA KIT 125
- K Number
- K821145
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1245
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nuclear Medical Systems, Inc.
- Date Received
- April 21, 1982
- Decision Date
- May 14, 1982
- Product Code
- JKC
- 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 |
|---|---|---|---|
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | FDA class 1 | Clinical Chemistry |
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