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FDA 510(k) Applications Submitted by Stacy Ferguson
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140354
02/12/2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
ABBOTT MOLECULAR, INC.
K241573
06/03/2024
Alinity m Resp-4-Plex
Abbott Molecular Inc
K241580
06/03/2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
Abbott Molecular
K233349
09/29/2023
Alinity m HSV 1 & 2 / VZV
Abbott Molecular Inc
K202977
09/30/2020
Alinity m STI Assay
Abbott Molecular, Inc.
K243410
11/01/2024
simpli-COLLECT STI Test
Abbott Molecular
K243485
11/08/2024
Alinity m CMV
Abbott Molecular Inc.
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