THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
FDA 510(k) clearance K012525 · decided 2001-10-04
Clearance details
- K-number
- K012525
- Device name
- THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
- Applicant
- Thermo Dma, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-06
- Decision date
- 2001-10-04
- Days to decision
- 59 days
- Clearance type
- Abbreviated
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Arlington, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.