ENDOTACK

FDA 510(k)

FDA Class 2 ·Orthopedic

KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STACLOT PROTEIN C TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

PTT-LA TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

THE STACHROM HEPARIN ASSAY KIT

FDA 510(k)

FDA Class 2 ·Hematology

KSEA MEDI PACK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASSERACHROM PF4 KIT

FDA 510(k)

FDA Class 2 ·Hematology

STACLOT LA TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

NEOPLASTINE CI PLUS

FDA 510(k)

FDA Class 2 ·Hematology

UNIDRIVE II PLUS DISPOSABLE TUBING SET

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNICALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THROMBO-CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·FLEX-CARE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

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