Alinity m CMV— 510(k) K243485
Substantially EquivalentAbbott Molecular, Inc.
FDA 510(k) clearance K243485 for Alinity m CMV, Substantially Equivalent on 2025-07-01. Applicant: Abbott Molecular, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Molecular, Inc.
- Product code
- Code PAB
- Device class
- Class 2
- Regulation
- 21 CFR 866.3180
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
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