ABB VIE J

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAPARETTE, MODEL LAP J L S H N

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

XTRACTOR, MODEL M143

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear

FDA 510(k)

FDA Class 2 ·Ophthalmic

3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE

FDA 510(k)

FDA Class 2 ·Radiology

IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)

FDA Class 2 ·Immunology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Vista MMB Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry