FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I ESTRIOL
K Number: K790008
·
Decision Feb 26, 1979
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
5
Review Days
55
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Basic Information
- Device Name
- I ESTRIOL
- K Number
- K790008
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Nuclear Corp.
- Date Received
- January 2, 1979
- Decision Date
- February 26, 1979
- Product Code
- CGI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
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