FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTIMUNE ESTRIOL RIA
K Number: K811709
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
319
Review Days
23
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Basic Information
- Device Name
- QUANTIMUNE ESTRIOL RIA
- K Number
- K811709
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- June 17, 1981
- Decision Date
- July 10, 1981
- Product Code
- CGI
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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