QKE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoassay, Pregnanediol Glucuronide, Over The Counter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1620
- Medical specialty
- Clinical Chemistry
- FDA definition
- Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
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| Record | Firm | Date |
|---|---|---|
| Proov Test (K191462) | Mfb Fertility, Inc. | 2020-02-27 |
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Every clearance here is in the API, with alerts when new ones post.