FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DHEA-S RIA KIT
K Number: K872879
·
Decision Oct 23, 1987
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
27
Applicant Total
2
Review Days
94
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Basic Information
- Device Name
- DHEA-S RIA KIT
- K Number
- K872879
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1245
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Endocrine Associates, Inc.
- Date Received
- July 21, 1987
- Decision Date
- October 23, 1987
- 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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Other Clearances by Endocrine Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872880 | CALCITONIN RIA KIT | Aug 13, 1987 | Substantially Equivalent |