FREND Testosterone Test System— 510(k) K153577
Substantially EquivalentNanoentek USA, Inc.
FDA 510(k) clearance K153577 for FREND Testosterone Test System, Substantially Equivalent on 2016-10-14. Applicant: Nanoentek USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Nanoentek USA, Inc.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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