FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTIMUNE E3 RIA
K Number: K802944
·
Decision Dec 22, 1980
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
319
Review Days
33
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Basic Information
- Device Name
- QUANTIMUNE E3 RIA
- K Number
- K802944
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- November 19, 1980
- Decision Date
- December 22, 1980
- Product Code
- CGI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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