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 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

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

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 (K6451)

Electrode, Ion Specific, Potassium

FDA classification

FDA Class 2 ·Electrode, Ion Specific, Potassium

Hemoglobin, Chain Specific, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Hemoglobin, Chain Specific, Antigen, Antiserum, Control

Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reverso Pro System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MONOHAEM (FECAL OCCULT BLOOD TEST)

FDA 510(k)

FDA Class 2 ·Hematology

PHENOBARBITAL FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FILMSAVER, NT VERSION 5.03

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOVASCULAR ARRAY

FDA 510(k)

FDA Class 2 ·Radiology

CPR MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIMENSION DRUG CALIBRATOR, MODEL DC22B

FDA 510(k)

FDA Class 2 ·Clinical Chemistry