CYTO-CHEX BCT
FDA 510(k) clearance K080552 · decided 2008-07-31
Clearance details
- K-number
- K080552
- Device name
- CYTO-CHEX BCT
- Applicant
- Streck
- Decision
- Substantially Equivalent
- Date received
- 2008-02-28
- Decision date
- 2008-07-31
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- GIM
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- La Vista, NE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. St recall (Z-1684-2017) | Streck | 2017-03-08 |