COULTER MAXM W/ AUTOLOADER
FDA 510(k) clearance K922704 · decided 1992-07-27
Clearance details
- K-number
- K922704
- Device name
- COULTER MAXM W/ AUTOLOADER
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-05
- Decision date
- 1992-07-27
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hialeah, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader Part number: 670 recall (Z-0602-2012) | Beckman Coulter Inc. | 2012-01-11 |