LNW
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Paper, Obstetric Ph
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 1994: 1 · 1996: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| PHEM-ALERT (K032161) | Femtek,Llc. | 2003-09-30 | + Add |
| PHEM-ALERT (K012230) | Femtek,Llc. | 2001-10-09 | + Add |
| PHEM-CHEK (K960648) | Femtek, Inc. | 1996-05-13 | + Add |
| OB-PH - PH TEST PAPER (K850858) | Uro Pharmaceuticals, Inc. | 1985-05-24 | + Add |
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Every clearance here is in the API, with alerts when new ones post.