Alinity m EBV (09N43-095)
K-Number: K243489 · 2025-07-28
ApplicantAbbott Molecular, Inc.
Decision Date2025-07-28
Product CodeQLX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Alinity m EBV (09N43-095) is a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-07-28 under approval number K243489. The device is classified under product code QLX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alinity m EBV (09N43-095)?
Alinity m EBV (09N43-095) is a medical device that received FDA 510(k) clearance on 2025-07-28. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K243489.
When was Alinity m EBV (09N43-095) approved by the FDA?
Alinity m EBV (09N43-095) received FDA 510(k) clearance on 2025-07-28, under approval number K243489.
What company makes Alinity m EBV (09N43-095)?
Alinity m EBV (09N43-095) is manufactured by Abbott Molecular, Inc..
What is the FDA product code for Alinity m EBV (09N43-095)?
The FDA product code for Alinity m EBV (09N43-095) is QLX.
Other Devices by Abbott Molecular, Inc.
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K203220cobas BKVRoche Molecular Systems, Inc.
K212778Alinity 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)Abbott Molecular, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.