QC-BEADS— 510(k) K042750
Substantially EquivalentBioscreen, Inc.
FDA 510(k) clearance K042750 for QC-BEADS, Substantially Equivalent on 2004-10-29. Applicant: Bioscreen, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioscreen, Inc.
- Product code
- Code NRF
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code NRF
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