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Abbott Molecular, Inc.

17 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Alinity m HCV (K252102)Abbott Molecular, Inc.2025-09-25
Alinity m EBV (09N43-095) (K243489)Abbott Molecular, Inc.2025-07-28
Alinity m CMV (K243485)Abbott Molecular, Inc.2025-07-01
Alinity m BKV (K241921)Abbott Molecular, Inc.2025-03-24
Alinity m Resp-4-Plex (K241573)Abbott Molecular, Inc.2025-02-14
Alinity m HSV 1 & 2 / VZV (K233349)Abbott Molecular, Inc.2024-05-03
Alinity m STI Assay (K222379)Abbott Molecular, Inc.2023-03-03
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) (K212778)Abbott Molecular, Inc.2022-07-15
Alinity m STI Assay (K202977)Abbott Molecular, Inc.2022-04-29
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (K140354)Abbott Molecular, Inc.2014-05-09
VYSIS D7S486/CEP 7 FISH PROBE KIT (K131508)Abbott Molecular, Inc.2013-09-13
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) (DEN130010)Abbott Molecular, Inc.2013-07-29
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 (K091960)Abbott Molecular, Inc.2011-08-29
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 (K100015)Abbott Molecular, Inc.2011-08-09
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 (K092704)Abbott Molecular, Inc.2010-05-28
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 (K092705)Abbott Molecular, Inc.2010-05-28
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT (K080739)Abbott Molecular, Inc.2008-07-10

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Every clearance here is in the API, with alerts when new ones post.