FSH Maiaclone Immunoradiometric Assay Kit
FDA 510(k) K862813 · Serono Diagnostics, Inc.
510(k) numberK862813
Submission
- Device name
- FSH Maiaclone Immunoradiometric Assay Kit
- Applicant
- Serono Diagnostics, Inc.
Norwell, MA, US - Received
- July 24, 1986
- Decision date
- September 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGJ – Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Specialty
- Clinical Chemistry
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Questions and answers
When was FSH Maiaclone Immunoradiometric Assay Kit cleared by the FDA?
FSH Maiaclone Immunoradiometric Assay Kit (K862813) received a 510(k) decision of Substantially Equivalent on September 16, 1986, 54 days after the submission was received.
What is the product code of K862813?
The FDA product code is CGJ – Radioimmunoassay, Follicle-Stimulating Hormone, a Class I (low risk) device regulated under 21 CFR 862.1300.