ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
FDA 510(k) clearance K102647 · decided 2011-03-24
Clearance details
- K-number
- K102647
- Device name
- ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
- Applicant
- Elitechgroup Vital Scientific BV
- Decision
- Substantially Equivalent
- Date received
- 2010-09-14
- Decision date
- 2011-03-24
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of t recall (Z-0006-2015) | ELITech Clinical Systems SAS | 2014-10-02 |