ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Jak2 Gene Mutation Detection Test

FDA classification

FDA Class 2 ·Jak2 Gene Mutation Detection Test

ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

Perfetta Moderate Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS(TM) LITHOTRIPTER

UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35

FDA 510(k)

FDA Class 2 ·Radiology

ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124

FDA 510(k)

FDA Class 2 ·Radiology

VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUMINEX LX 100/200 INSTRUMENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ESENSOR WARFARIN SENSITIVITY SALIVA TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FilmArray 2.0 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DENV DETECT IGM CAPTURE ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMINA BEADXPRESS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ePlex Instrument

FDA 510(k)

FDA Class 2 ·Clinical Chemistry