ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
FDA 510(k) clearance K112029 · decided 2011-08-30
Clearance details
- K-number
- K112029
- Device name
- ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
- Applicant
- Elitechgroup
- Decision
- Substantially Equivalent
- Date received
- 2011-07-15
- Decision date
- 2011-08-30
- Days to decision
- 46 days
- Clearance type
- Abbreviated
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- 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
No recalls on record reference this clearance.