ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
FDA 510(k) clearance K151552 · decided 2015-07-08
Clearance details
- K-number
- K151552
- Device name
- ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- Applicant
- Elitechgroup
- Decision
- Substantially Equivalent
- Date received
- 2015-06-09
- Decision date
- 2015-07-08
- Days to decision
- 29 days
- Clearance type
- Abbreviated
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sees, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.