HD-550 Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Antithrombin Iii, Two Stage Clotting Time Assay

FDA classification

FDA Class 2 ·Antithrombin Iii, Two Stage Clotting Time Assay

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Non-Invasive Central Venous Manometer

FDA classification

FDA Class 2 ·Non-Invasive Central Venous Manometer

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Sunlamp Products (Pre-Standard)

FDA classification

FDA Class 2 ·Sunlamp Products (Pre-Standard)

Reagents For Detection Of Norovirus Nucleic Acid

FDA classification

FDA Class 2 ·Reagents For Detection Of Norovirus Nucleic Acid

Goniometer With Electrodes

FDA classification

FDA Class 2 ·Goniometer With Electrodes

Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

FDA classification

FDA Class 2 ·Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

FDA classification

FDA Class 2 ·Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt

Colposcope (And Colpomicroscope), Exempt

FDA classification

FDA Class 2 ·Colposcope (And Colpomicroscope), Exempt

System, Peritoneal, Automatic Delivery, Exempt

FDA classification

FDA Class 2 ·System, Peritoneal, Automatic Delivery, Exempt

Tympanometer, Exempt

FDA classification

FDA Class 2 ·Tympanometer, Exempt

Analyzer, Nitrogen Dioxide, Exempt

FDA classification

FDA Class 2 ·Analyzer, Nitrogen Dioxide, Exempt

Analyzer, Body Composition, Exempt

FDA classification

FDA Class 2 ·Analyzer, Body Composition, Exempt