COULTER(R) MH010
FDA 510(k) clearance K911385 · decided 1991-06-17
Clearance details
- K-number
- K911385
- Device name
- COULTER(R) MH010
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-28
- Decision date
- 1991-06-17
- Days to decision
- 81 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 and MAXM Hematology Analyzer with Autoloader. Hematology recall (Z-1731-2011) | Beckman Coulter Inc. | 2011-03-18 |