ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
FDA 510(k) clearance K103376 · decided 2011-11-18
Clearance details
- K-number
- K103376
- Device name
- ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
- Applicant
- Seppim S.A.S.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-17
- Decision date
- 2011-11-18
- Days to decision
- 366 days
- Clearance type
- Traditional
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- 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.