SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
FDA 510(k) clearance K171476 · decided 2018-02-27
Clearance details
- K-number
- K171476
- Device name
- SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
- Applicant
- Awareness Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-19
- Decision date
- 2018-02-27
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Palm City, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.