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

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

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

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

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, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0

STAGO FACTOR XI-DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

AT-III CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology