SD-730 IF-SDS, PERFECT PULSE IF-SDS

FDA 510(k)

FDA Class 2 ·Neurology

CONDUCTIVE GEL FOR ULTRASOUND

FDA 510(k)

FDA Class 2 ·Neurology

CSF/URINE TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)

FDA Class 2 ·Neurology

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

IF-727 INTERFERENTIAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

FDA Pre-Market Approval

ETI-AB-COREK PLUS Assay

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS Assay

FDA Pre-Market Approval

ETI-CORE-IGMK PLUS Assay

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-EBK PLUS Assay

FDA Pre-Market Approval

ETI-AB-EBK PLUS Assay

VITAMIN A PLUS E

FDA UDI

UTAK LABORATORIES, INC.·B800VITAEQCSCSU0·VITAMIN A PLUS E

PAG MICROPROCESSOR-CONTROLLED MODULE

FDA 510(k)

FDA Class 1 ·Cardiovascular

LIFE SOUND SENSOR

FDA 510(k)

FDA Class 1 ·Cardiovascular

DSP100 AMPLIFIER

FDA 510(k)

FDA Class 1 ·Cardiovascular

ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE

FDA 510(k)

FDA Class 1 ·Cardiovascular

PULSE/PHONOCARDIOGRAPHY CHANNEL, 144

FDA 510(k)

FDA Class 1 ·Cardiovascular

MODIFIED DSP100 AMPLIFIER

FDA 510(k)

FDA Class 1 ·Cardiovascular

CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH

FDA 510(k)

FDA Class 1 ·Cardiovascular