LIFESIGN DXPRESS, MODEL LSR2000
FDA 510(k) clearance K050955 · decided 2006-01-23
Clearance details
- K-number
- K050955
- Device name
- LIFESIGN DXPRESS, MODEL LSR2000
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-15
- Decision date
- 2006-01-23
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Monmouth Junction, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.