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| Document Number | CR260334 |
| Test Name | Phamatech, Inc., QuickScreen At Home Digital Ovulation Test |
| Manufacturer Name | Hangzhou AllTest Biotech Co., Ltd. |
| Consumer Information Phone Number | 1(800)635-5840 |
| Test Type | Luteinizing hormone (LH) |
| Effective Date | 06/12/2026 |
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| Device Name | QuickScreen At Home Digital Ovulation Test |
| 510(K) Exempt Number | CR260334 |
| Panel Name |
Clinical Chemistry
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| Applicant |
| Hangzhou AllTest Biotech Co., Ltd. |
#550 yinhai st. |
hangzhou economic & technologi |
hangzhou,
31001 8 |
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| Contact | rosa wu |
| Date Received | 04/21/2026 |
| Decision Date | 06/12/2026 |
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