MASSTRAK IMMUNOSUPPRESSANTS KIT
FDA 510(k) clearance K063868 · decided 2007-05-25
Clearance details
- K-number
- K063868
- Device name
- MASSTRAK IMMUNOSUPPRESSANTS KIT
- Applicant
- Waters Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-12-29
- Decision date
- 2007-05-25
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- MLM
- Device class
- 2
- Regulation number
- 862.1678
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.