PHEM-CHEK— 510(k) K960648
Substantially EquivalentFemtek, Inc.
FDA 510(k) clearance K960648 for PHEM-CHEK, Substantially Equivalent on 1996-05-13. Applicant: Femtek, Inc.. Device class: 1.
Clearance details
- Applicant
- Femtek, Inc.
- Product code
- Code LNW
- Device class
- Class 1
- Regulation
- 21 CFR 862.1550
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pasadena, CA, US
Recent devices under product code LNW
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