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Abbott Molecular, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories13
Latest FDA decision2026-07-23
TypeNumberDevice NameCodeDateActions
PMA P230003 KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSMAQ2026-07-23 View
PMA P170005 Somatic gene mutation detection systemOWD2026-05-28 View
PMA P170041 Somatic gene mutation detection systemOWD2026-05-28 View
PMA P110012 Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangementOWE2026-02-18 View
PMA P150041 Fluorescence in situ hybridization, chromosome 17p deletion (TP53)PNK2026-02-18 View
PMA P200013 Hepatitis Viral B DNA DetectionMKT2025-10-17 View
510(k) K252102 Alinity m HCVMZP2025-09-25 View
510(k) K243489 Alinity m EBV (09N43-095)QLX2025-07-28 View
510(k) K243485 Alinity m CMVPAB2025-07-01 View
PMA P080026 Hepatitis Viral B DNA DetectionMKT2025-04-18 View
510(k) K241921 Alinity m BKVQMI2025-03-24 View
510(k) K241573 Alinity m Resp-4-PlexQOF2025-02-14 View
PMA P210022 Cytomegalovirus (cmv) dna quantitative assayPAB2024-09-13 View
510(k) K233349 Alinity m HSV 1 & 2 / VZVPGI2024-05-03 View
510(k) K222379 Alinity m STI AssayQEP2023-03-03 View
510(k) K212778 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)QLX2022-07-15 View
510(k) K202977 Alinity m STI AssayQEP2022-04-29 View
PMA P980024 SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUMMVD2022-03-18 View
PMA P190025 Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusMZP2021-06-01 View
PMA P100017 Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusMZP2021-03-05 View
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