CONTROL PLASMA N, PROC CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

FDA 510(k)

FDA Class 2 ·Hematology

Supreme and Response Electrophysiology Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed Synthes External Fixation Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

ENZYME II CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTROL PLASMA N

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISA HBA1C, MODEL K3105A

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 VANCOMYCIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

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