RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE (Colors & Flavors), SKORE (Colors)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COMPACT WHEELCHAIR PLATFORM

FDA 510(k)

FDA Class 2 ·Physical Medicine

PASR/QUIETNITE

FDA 510(k)

FDA Class 2 ·Dental

VOXAR'S CALCIUM SCORING PRODUCT

FDA 510(k)

FDA Class 2 ·Radiology

VOXAR VC, MODEL 1.0

FDA 510(k)

FDA Class 2 ·Radiology

VOXAR 3D PRODUCT FAMILY

FDA 510(k)

FDA Class 2 ·Radiology