DUET SYSTEM— 510(k) K040591
Substantially EquivalentBioview , Ltd.
FDA 510(k) clearance K040591 for DUET SYSTEM, Substantially Equivalent on 2004-09-16. Applicant: Bioview , Ltd.. Device class: 2.
Clearance details
- Applicant
- Bioview , Ltd.
- Product code
- Code JOY
- Device class
- Class 2
- Regulation
- 21 CFR 864.5260
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
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More clearances from Bioview , Ltd.
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