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FDA 510(k)

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)

K-Number: K212778 · 2022-07-15

ApplicantAbbott Molecular, Inc.
Decision Date2022-07-15
Product CodeQLX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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) is a medical device manufactured by Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2022-07-15 under approval number K212778. 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 AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)?

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) is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Abbott Molecular, Inc.. The 510(k) number is K212778.

When was 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) approved by the FDA?

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) received FDA 510(k) clearance on 2022-07-15, under approval number K212778.

What company makes 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)?

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) is manufactured by Abbott Molecular, Inc..

What is the FDA product code 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)?

The FDA product code 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) is QLX.

Other Devices by Abbott Molecular, Inc.

K202977Alinity m STI Assay K222379Alinity m STI Assay K233349Alinity m HSV 1 & 2 / VZV K252102Alinity m HCV K243489Alinity m EBV (09N43-095) K243485Alinity m CMV

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Related Devices (Code: QLX)

DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. K203220cobas BKVRoche Molecular Systems, Inc. K243489Alinity m EBV (09N43-095)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.

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