STA R Max 3, STA Compact Max 3
FDA 510(k) clearance K212183 · decided 2023-06-07
Clearance details
- K-number
- K212183
- Device name
- STA R Max 3, STA Compact Max 3
- Applicant
- Diagnostica Stago S.A.S
- Decision
- Substantially Equivalent
- Date received
- 2021-07-13
- Decision date
- 2023-06-07
- Days to decision
- 694 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Asniéres Sur Seine, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.