QKE — Immunoassay, Pregnanediol Glucuronide, Over The Counter Class I
FDA product code QKE covers "Immunoassay, Pregnanediol Glucuronide, Over The Counter", a Class I medical device regulated under 21 CFR 862.1620. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QKE
- Device Class
- Class I
- Regulation Number
- 862.1620
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191462 | mfb fertility | Proov Test | February 27, 2020 |