AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD

FDA 510(k)

FDA Class 2 ·Radiology

ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE

FDA 510(k)

FDA Class 2 ·Immunology

SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

FDA 510(k)

FDA Class 2 ·Radiology

HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANDIDA DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS

FDA 510(k)

FDA Class 2 ·Microbiology

DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Interlude Rolled Tampons in Plastic Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Interlude 100% Cotton Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

YO Home Sperm Test

FDA 510(k)

FDA Class 2 ·Hematology

Interlude and private label Unscented 3-piece compact applicator tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK B12 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

'NO-BOIL' VITAMIN B12 KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIAISON Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITAMIN B12 - NO-BOIL KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry