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Abbott Molecular, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
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
510(k) K241921 Alinity m BKVQMI2025-03-24 View
510(k) K241573 Alinity m Resp-4-PlexQOF2025-02-14 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
510(k) K131508 VYSIS D7S486/CEP 7 FISH PROBE KITPFG2013-09-13 View
510(k) K091960 VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020OWK2011-08-29 View
510(k) K100015 VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34OVQ2011-08-09 View
510(k) K092704 ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03LSK2010-05-28 View
510(k) K092705 ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501OOI2010-05-28 View
510(k) K080739 ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITMKZ2008-07-10 View
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