FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECSYS DHEA-S
K Number: K003174
·
Decision Jan 17, 2001
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
27
Applicant Total
264
Review Days
99
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Basic Information
- Device Name
- ELECSYS DHEA-S
- K Number
- K003174
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1245
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- October 10, 2000
- Decision Date
- January 17, 2001
- 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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