FREND Testosterone Test System
FDA 510(k) clearance K153577 · decided 2016-10-14
Clearance details
- K-number
- K153577
- Device name
- FREND Testosterone Test System
- Applicant
- Nanoentek USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-15
- Decision date
- 2016-10-14
- Days to decision
- 304 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.