Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)— 510(k) K212778
Substantially EquivalentAbbott Molecular, Inc.
FDA 510(k) clearance K212778 for Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075), Substantially Equivalent on 2022-07-15. Applicant: Abbott Molecular, Inc..
Clearance details
- Applicant
- Abbott Molecular, Inc.
- Product code
- Code QLX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.