DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology

PT-MULTI-CALIBRATOR, MODEL OPAT07

FDA 510(k)

FDA Class 2 ·Hematology

OT EQUATOR

FDA 510(k)

FDA Class 2 ·Dental

TANDA MAX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA SKINCARE SYSTEM, MODEL: PTSCS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANDA RESTORE, MODEL PTSCS

FDA 510(k)

FDA Class 2 ·Physical Medicine

FETAL D TECTION KIT

FDA 510(k)

FDA Class 2 ·Hematology

GAMMA FETAL BLEED SCREENING TEST

FDA 510(k)

FDA Class 2 ·Hematology

EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex Reagent Cartridge

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION PSA FLEX REAGENT CARTRIDGE