SYSMEX POCH-100I
FDA 510(k) clearance K032677 · decided 2004-02-11
Clearance details
- K-number
- K032677
- Device name
- SYSMEX POCH-100I
- Applicant
- Sysmex America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-29
- Decision date
- 2004-02-11
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- GKL
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex recall (Z-0100-2014) | Sysmex America Inc | 2013-10-18 |