SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
FDA 510(k) clearance K965108 · decided 1997-03-06
Clearance details
- K-number
- K965108
- Device name
- SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-20
- Decision date
- 1997-03-06
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DEW
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Cou recall (Z-2226-2011) | Beckman Coulter Inc. | 2011-05-20 |
| SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920 recall (Z-2653-2010) | Beckman Coulter Inc. | 2010-09-30 |