DUET SYSTEM
FDA 510(k) clearance K040591 · decided 2004-09-16
Clearance details
- K-number
- K040591
- Device name
- DUET SYSTEM
- Applicant
- Bioview , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-08
- Decision date
- 2004-09-16
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- JOY
- Device class
- 2
- Regulation number
- 864.5260
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.