Cell-Free DNA BCT— 510(k) K231776
Substantially EquivalentStreck, Inc.
FDA 510(k) clearance K231776 for Cell-Free DNA BCT, Substantially Equivalent on 2024-07-26. Applicant: Streck, Inc.. Device class: 2.
Clearance details
- Applicant
- Streck, Inc.
- Product code
- Code QMA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1676
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Vista, NE, US
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