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FDA 510(k) Applications Submitted by Abbott Molecular
FDA 510(k) Number
Submission Date
Device Name
Applicant
K241580
06/03/2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
Abbott Molecular
K243410
11/01/2024
simpli-COLLECT STI Test
Abbott Molecular
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