SeptiCyte RAPID— 510(k) K232095
Substantially EquivalentImmunexpress, Inc.
FDA 510(k) clearance K232095 for SeptiCyte RAPID, Substantially Equivalent on 2023-12-15. Applicant: Immunexpress, Inc.. Device class: 2.
Clearance details
- Applicant
- Immunexpress, Inc.
- Product code
- Code PRE
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code PRE
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