PREGNA-ZYME

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANSWER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN EXTRA STRENGTH LUBRICATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BACTIGEN(R) N. MENINGITIDIS

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION OF MONO-PLUS(TM)

FDA 510(k)

FDA Class 2 ·Immunology

TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TROJAN EXTRA LARGE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MONO-LATEX (TM) SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

VIROGEN RUBELLA SLIDE TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TBD AT-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BACTIGEN(R) H. INFLUENZAE TYPE B

FDA 510(k)

FDA Class 2 ·Microbiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

FDA 510(k)

FDA Class 2 ·Hematology

MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15

FDA 510(k)

FDA Class 2 ·Radiology

AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

DETRUSAN 500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology