Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)— 510(k) K241580
Substantially EquivalentAbbott Molecular
FDA 510(k) clearance K241580 for Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086), Substantially Equivalent on 2024-12-06. Applicant: Abbott Molecular. Device class: 2.
Clearance details
- Applicant
- Abbott Molecular
- Product code
- Code QQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
Recent devices under product code QQX
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