STA LIATEST FREE PS
FDA 510(k) clearance K092170 · decided 2009-12-22
Clearance details
- K-number
- K092170
- Device name
- STA LIATEST FREE PS
- Applicant
- Diagnostica Stago, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-21
- Decision date
- 2009-12-22
- Days to decision
- 154 days
- Clearance type
- Special
- Product code
- GGP
- Device class
- 2
- Regulation number
- 864.7290
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parisppany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.