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Hologic, Inc.

FDA 510(k) & PMA Approved Dispositivos — 45 products

Total de dispositivos45
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K254090 I-View®MUE2026-09-02 Ver
510(k) K262792 Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW2026-08-12 Ver
510(k) K253634 CoolSeal Generator® (CSL-200-90)GEI2026-06-17 Ver
510(k) K251993 Panther Fusion GI Expanded Bacterial AssayPCH2025-09-25 Ver
510(k) K243341 Genius AI Detection 2.0QDQ2025-07-31 Ver
510(k) K243396 Aptima SARS-CoV-2 AssayQQX2025-02-13 Ver
510(k) K243935 Aptima CMV Quant AssayPAB2025-01-17 Ver
510(k) K243345 Aptima BV Assay; Aptima CV/TV AssayPQA2024-11-25 Ver
510(k) K242465 Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF2024-11-15 Ver
510(k) K240886 Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)HIG2024-07-25 Ver
510(k) K233352 Aptima HCV Quant Dx EnsaioMZP2024-07-24 Ver
510(k) K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2024-07-18 Ver
510(k) K231329 Aptima Neisseria gonorrhoeae EnsaioLSL2024-01-26 Ver
510(k) K230451 Aptima® Chlamydia trachomatis AssayMKZ2023-11-16 Ver
510(k) K231316 Aptima Trichomonas vaginalis AssayOUY2023-11-06 Ver
510(k) K230096 Genius AI Detection 2.0 with CC-MLO CorrelationQDQ2023-05-23 Ver
510(k) K222736 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2023-05-16 Ver
510(k) K231017 Panther Fusion AdV/hMPV/RV AssayOCC2023-05-05 Ver
510(k) K221449 Genius AI Detection 2.0QDQ2022-10-06 Ver
510(k) K220321 Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) TigrisQEP2022-06-03 Ver
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