免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

Hologic, Inc.

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

器械总数45
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K254090 I-View®MUE2026-09-02 查看
510(k) K262792 Brevera活检系统，配备CorLumina成像技术（BREVDISP09）KNW2026-08-12 查看
510(k) K253634 CoolSeal 生成器® (CSL-200-90)GEI2026-06-17 查看
510(k) K251993 Panther Fusion GI Expanded Bacterial AssayPCH2025-09-25 查看
510(k) K243341 Genius AI Detection 2.0QDQ2025-07-31 查看
510(k) K243396 Aptima SARS-CoV-2 AssayQQX2025-02-13 查看
510(k) K243935 Aptima CMV Quant AssayPAB2025-01-17 查看
510(k) K243345 Aptima BV Assay; Aptima CV/TV AssayPQA2024-11-25 查看
510(k) K242465 Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF2024-11-15 查看
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 查看
510(k) K233352 Aptima HCV Quant Dx AssayMZP2024-07-24 查看
510(k) K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2024-07-18 查看
510(k) K231329 Aptima Neisseria gonorrhoeae AssayLSL2024-01-26 查看
510(k) K230451 Aptima® Chlamydia trachomatis AssayMKZ2023-11-16 查看
510(k) K231316 Aptima Trichomonas vaginalis AssayOUY2023-11-06 查看
510(k) K230096 Genius AI Detection 2.0 with CC-MLO CorrelationQDQ2023-05-23 查看
510(k) K222736 Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2023-05-16 查看
510(k) K231017 Panther Fusion AdV/hMPV/RV AssayOCC2023-05-05 查看
510(k) K221449 Genius AI Detection 2.0QDQ2022-10-06 查看
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 查看
↑