ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
FDA 510(k) clearance K100525 · decided 2010-12-15
Clearance details
- K-number
- K100525
- Device name
- ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
- Applicant
- Seppim S.A.S.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-24
- Decision date
- 2010-12-15
- Days to decision
- 294 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- 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 |
|---|---|---|
| Eon 100 system included the following product reference numbers and names: Reference no. 7 recall (Z-0214-2016) | ELITech Clinical Systems SAS | 2015-11-05 |
| Eon 300 system includes the following product reference numbers and names: Reference no. 7 recall (Z-0215-2016) | ELITech Clinical Systems SAS | 2015-11-05 |
| ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize recall (Z-0216-2016) | ELITech Clinical Systems SAS | 2015-11-05 |
| Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 5 recall (Z-0217-2016) | ELITech Clinical Systems SAS | 2015-11-05 |