LOCI Total Vitamin D Total Assay, LOCI VITD CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

Archworx

FDA 510(k)

FDA Class 2 ·Dental

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSIONS HB1C KIT, MODEL DF105A

FDA 510(k)

FDA Class 2 ·Hematology

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION CHEMISTRY III CALIBRATORY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N APOLIPOPROTEIN STANDARD SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONTROL PLASMA N AND CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO STANDARD HUMAN PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SYVA EMIT II PLUS AMPHETAMINES ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology