SYNCHRON CX4-CE
FDA 510(k) clearance K904220 · decided 1990-10-15
Clearance details
- K-number
- K904220
- Device name
- SYNCHRON CX4-CE
- Applicant
- Beckman
- Decision
- Substantially Equivalent
- Date received
- 1990-09-12
- Decision date
- 1990-10-15
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SYNCHRON CX4 CE Clinical System Part #: 756600 Product Usage: The Beckman SYNCHRON CX4 DEL recall (Z-0126-2012) | Beckman Coulter Inc. | 2011-10-27 |