Atellica® CH Diazo Total Bilirubin (D_TBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

FDA 510(k)

FDA Class 2 ·Immunology

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROTEIN S AC

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 VANCOMYCIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOCI 8 CALIBRATOR, MODEL KC 646

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CV PERI-GUARD AND VASCU-GUARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

PALMLIGHT

FDA 510(k)

FDA Class 2 ·Dental

OCU-GUARD AND OCU-GUARD SUPPLE

FDA 510(k)

FDA Class 2 ·Ophthalmic

BRANEMARK SYSTEM DEC 600 DRILLING UNIT

FDA 510(k)

FDA Class 2 ·Dental

W & H LISA STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

COMBI 8 MAX

FDA 510(k)

FDA Class 2 ·Physical Medicine

A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM

FDA 510(k)

FDA Class 2 ·Dental

CAREMIBRAIN

FDA 510(k)

FDA Class 2 ·Radiology