Estrone Analysis Products Radioimmunoassay Estrone
FDA 510(k) K864966 · Diagnostics Biochem Canada, Inc.
510(k) numberK864966
Submission
- Device name
- Estrone Analysis Products Radioimmunoassay Estrone
- Applicant
- Diagnostics Biochem Canada, Inc.
London, Ontario, CA - Received
- December 22, 1986
- Decision date
- January 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGF – Radioimmunoassay, Estrone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1280
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970915 | DSL Estrone-Sulfate RiaCGF · Traditional | Diagnostic Systems Laboratories, Inc. | 05/16/1997SE |
| K935013 | DSL Estrone (DSL 8700)CGF · Traditional | Diagnostic Systems Laboratories, Inc. | 06/16/1994SE |
| K833406 | Immophase D-Te 3 RadioimmunoassayCGF · Traditional | Corning Medical & Scientific | 01/24/1984SE |
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Questions and answers
When was Estrone Analysis Products Radioimmunoassay Estrone cleared by the FDA?
Estrone Analysis Products Radioimmunoassay Estrone (K864966) received a 510(k) decision of Substantially Equivalent on January 9, 1987, 18 days after the submission was received.
What is the product code of K864966?
The FDA product code is CGF – Radioimmunoassay, Estrone, a Class I (low risk) device regulated under 21 CFR 862.1280.