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Medical Genetics

17 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit (K252243)Suzhou Precigenome, Ltd. Co;2026-07-02
BCR-ABL1 (p210) % IS Kit (Digital PCR Method) (K221869)Suzhou Sniper Medical Technologies Co., Ltd.2023-09-05
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (K223597)23AndMe, Inc.2023-08-31
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (K221885)23AndMe, Inc.2022-10-26
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (K211499)23AndMe, Inc.2022-01-06
Helix Laboratory Platform (DEN190035)Helix Opco, LLC2020-12-23
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (K193492)23AndMe, Inc.2020-08-17
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems (K190076)Cepheid2019-09-27
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (K181661)Bio-Rad Laboratories, Inc.2019-02-13
MUTYH-Associated Polyposis (MAP) (K182784)23AndMe, Inc.2019-01-18
MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit (DEN170070)Cytocell, Ltd.2018-12-21
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (DEN180028)23AndMe, Inc.2018-10-31
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (DEN170046)23AndMe, Inc.2018-03-06
ipsogen JAK2 RGQ PCR Kit (K172287)Qiagen, Inc.2018-01-12
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software (K173492)Molecularmd Corporation2017-12-22
ipsogen JAK2 RGQ PCR Kit (DEN160028)Qiagen, Inc.2017-03-27
Quantidex qPCR BCR-ABL IS Kit (DEN160003)Asuragen, Inc.2016-07-22

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