LIA Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSOM CARD PREGNANCY TEST, MODEL 103

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HOSPITAL LAB IN-HOME EARLY PREG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Distinct® Early Detection Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARPLAN EASY II HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FACTPLUS ONE STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Cryotop Vitrification Kit and Cryotop Thawing Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MIRAGE COMPLETE KIT AND MIRAGE ABC KIT

FDA 510(k)

FDA Class 2 ·Dental

GAMMA STICK CORTISOL RIA KIT/STICK KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV ASSAY, ABBOTT REALTIME HCV CALIBRATOR KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT MSAMPLE PREPARATI

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV