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

WAMPOLE HS-CRP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

DURAPHAT

FDA 510(k)

FDA Class 2 ·Dental

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

FDA 510(k)

FDA Class 2 ·Hematology

FIBEROPTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTARY* POWERED SCALPEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics