ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
FDA 510(k) clearance K033548 · decided 2003-11-24
Clearance details
- K-number
- K033548
- Device name
- ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-12
- Decision date
- 2003-11-24
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- 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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