HANDHELD BASE UNIT
FDA 510(k) clearance K072920 · decided 2008-01-31
Clearance details
- K-number
- K072920
- Device name
- HANDHELD BASE UNIT
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-15
- Decision date
- 2008-01-31
- Days to decision
- 108 days
- Clearance type
- Abbreviated
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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