SMARTPREP2 CENTRIFUGE SYSTEM
FDA 510(k) clearance K052925 · decided 2006-01-04
Clearance details
- K-number
- K052925
- Device name
- SMARTPREP2 CENTRIFUGE SYSTEM
- Applicant
- Harvest Technologies, Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-18
- Decision date
- 2006-01-04
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- JQC
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Plymouth, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.