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

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

FDA 510(k)

FDA Class 2 ·Medical Genetics

BOMED-NCCOM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO FITNESS COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAGNOSTIC MEDICAL COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BAIM CORONARY SINUS FLOW CALCULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVA 12 CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODELS 78551A 78552A

FDA 510(k)

FDA Class 2 ·Cardiovascular

QMED SYSTEM 2150

FDA 510(k)

FDA Class 2 ·Cardiovascular

IQ SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALPHA CARDIAC OUTPUT CARDULE #1899

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTINUOUS CARDIAC OUTPUT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

2200I PHYSIOLOGICAL MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE PLASTIC SYRINGE W/NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PulsioFlex Monitoring System with ProAQT Sensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

REAL-TIME SPECTRUM ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular