SYSMEX SE/RAM-1
FDA 510(k) clearance K964375 · decided 1997-03-13
Clearance details
- K-number
- K964375
- Device name
- SYSMEX SE/RAM-1
- Applicant
- Sysmex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-01
- Decision date
- 1997-03-13
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- GKL
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Long Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.