Radioimmunoassay, Estrone
The Radioimmunoassay, Estrone test system (product code CGF) is an in-vitro diagnostic device used in clinical chemistry to measure estrone, a form of estrogen, in serum or plasma using a radioimmunoassay technique. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. It falls under regulation 21 CFR 862.1280 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CGF
- Device Class
- FDA class 1
- Regulation Number
- 862.1280
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970915 | DSL ESTRONE-SULFATE RIA | May 16, 1997 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K935013 | DSL ESTRONE (DSL 8700) | Jun 16, 1994 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K864966 | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | Jan 09, 1987 | Substantially Equivalent | Diagnostics Biochem Canada, Inc. |
| K833406 | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY | Jan 24, 1984 | Substantially Equivalent | Corning Medical & Scientific |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.