IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
FDA 510(k) clearance K963048 · decided 1996-11-04
Clearance details
- K-number
- K963048
- Device name
- IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-06
- Decision date
- 1996-11-04
- Days to decision
- 90 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 |
|---|---|---|
| IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immuno recall (Z-0003-2013) | Beckman Coulter Inc. | 2012-10-01 |
| IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Nu recall (Z-2887-2011) | Beckman Coulter Inc. | 2011-07-27 |