OB-PH - PH TEST PAPER
FDA 510(k) clearance K850858 · decided 1985-05-24
Clearance details
- K-number
- K850858
- Device name
- OB-PH - PH TEST PAPER
- Applicant
- Uro Pharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-01
- Decision date
- 1985-05-24
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LNW
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Port Angeles, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PHEM-ALERT (K032161) | Femtek,Llc. | 2003-09-30 |
| PHEM-ALERT (K012230) | Femtek,Llc. | 2001-10-09 |
| PHEM-CHEK (K960648) | Femtek, Inc. | 1996-05-13 |
Recalls involving this device
No recalls on record reference this clearance.