SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
FDA 510(k) clearance K971788 · decided 1997-06-03
Clearance details
- K-number
- K971788
- Device name
- SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-14
- Decision date
- 1997-06-03
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- DHR
- Device class
- 2
- Regulation number
- 866.5775
- 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 Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunolog recall (Z-1194-2012) | Beckman Coulter Inc. | 2012-03-08 |
| SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used recall (Z-1743-2011) | Beckman Coulter Inc. | 2011-03-22 |