IMMAGE IMMUNOCHEMISTRY SYSTEM
FDA 510(k) clearance K962294 · decided 1996-08-21
Clearance details
- K-number
- K962294
- Device name
- IMMAGE IMMUNOCHEMISTRY SYSTEM
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-14
- Decision date
- 1996-08-21
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JQX
- Device class
- 1
- Regulation number
- 862.2700
- 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 |
|---|---|---|
| IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistr recall (Z-2045-2011) | Beckman Coulter Inc. | 2011-04-20 |
| IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650 recall (Z-2195-2010) | Beckman Coulter Inc. | 2010-08-10 |