FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
K Number: K800045
·
Decision Jan 23, 1980
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
83
Applicant Total
319
Review Days
15
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Basic Information
- Device Name
- QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
- K Number
- K800045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1205
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- January 8, 1980
- Decision Date
- January 23, 1980
- 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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