VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730

FDA 510(k)

FDA Class 2 ·Hematology

RADIAS B12 ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

D-10 HEMOGLOBIN A1C

FDA 510(k)

FDA Class 2 ·Hematology

COTUBE(TM) TSH IRMA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SoundBite Console, SoundBite Active Wire 18

FDA 510(k)

FDA Class 2 ·Cardiovascular

RADIAS NEONATAL T4 ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOGLOBIN A2 MICRO COLUMN TEST

FDA 510(k)

FDA Class 2 ·Hematology

D-100 HbA1c, D-100 HbA1c Calibrator Pack

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

FDA 510(k)

FDA Class 2 ·Hematology

COTUBE PTH IRMA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)

FDA 510(k)

FDA Class 2 ·General Hospital

OSSIFUSE BONE SUBSTITUTE MATERIAL

FDA 510(k)

FDA Class 2 ·Orthopedic

Hinscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

Precision Screw

FDA 510(k)

FDA Class 2 ·Neurology

SELITHERM, MODEL C100

FDA 510(k)

FDA Class 2 ·Physical Medicine

SoundBite® Crossing System XS Peripheral

FDA 510(k)

FDA Class 2 ·Cardiovascular

1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology