SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
FDA 510(k) clearance K950958 · decided 1995-05-08
Clearance details
- K-number
- K950958
- Device name
- SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-15
- Decision date
- 1995-05-08
- Days to decision
- 82 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 Delta Clinical System Part #: 468233 Product Usage: The Beckman SYNCHRON CX4 recall (Z-0125-2012) | Beckman Coulter Inc. | 2011-10-27 |
| SYNCHRON CX5 Delta Clinical System Part #: 468243 Product Usage: The Beckman SYNCHRON CX4 recall (Z-0128-2012) | Beckman Coulter Inc. | 2011-10-27 |
| SYNCHRON CX7 Delta Clinical System Part #: 468205 Product Usage: The Beckman SYNCHRON CX4 recall (Z-0131-2012) | Beckman Coulter Inc. | 2011-10-27 |
| SYNCHRON CX9 Delta ALX System Part #: 473513 Product Usage: The Beckman SYNCHRON CX4 DELTA recall (Z-0132-2012) | Beckman Coulter Inc. | 2011-10-27 |