FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOPHEIA CORTISOL EIA KIT
K Number: K822845
·
Decision Oct 27, 1982
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
83
Applicant Total
321
Review Days
34
Basic Information
- Device Name
- SOPHEIA CORTISOL EIA KIT
- K Number
- K822845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- Date Received
- September 23, 1982
- Decision Date
- October 27, 1982
- Product Code
- CGR
- 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 |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | FDA class 2 | Clinical Chemistry |
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