PHEM-ALERT
FDA 510(k) clearance K012230 · decided 2001-10-09
Clearance details
- K-number
- K012230
- Device name
- PHEM-ALERT
- Applicant
- Femtek,Llc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-16
- Decision date
- 2001-10-09
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LNW
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rockville, MD, 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-CHEK (K960648) | Femtek, Inc. | 1996-05-13 |
| OB-PH - PH TEST PAPER (K850858) | Uro Pharmaceuticals, Inc. | 1985-05-24 |
Recalls involving this device
No recalls on record reference this clearance.