System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

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

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

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

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M/HAVAB-M EIA/IMX HAVAB-M

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB-M 7180/ HAVAB-M EIA 9843/IMX HAVAB-M 2263

Geon (S2) Nasal Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842

FDA 510(k)

FDA Class 2 ·Neurology

SPACELABS MEDICAL MULTIPARAMETER MODULE 91496

FDA 510(k)

FDA Class 2 ·Cardiovascular

MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eia, Blastomyces Dermatitidis

FDA classification

FDA Class 2 ·Eia, Blastomyces Dermatitidis

GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%

FDA 510(k)

FDA Class 2 ·Ophthalmic

GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Geonic Nasal Aspirator, Geonic Nasal Cleaner

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Motex Anti-Fog Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cytokeratin Fragments 21-1 Eia Kit

FDA classification

FDA Class 2 ·Cytokeratin Fragments 21-1 Eia Kit

Control, Pump Speed, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Control, Pump Speed, Cardiopulmonary Bypass

Unit, Electrosurgical And Coagulation, With Accessories

FDA classification

FDA Class 2 ·Unit, Electrosurgical And Coagulation, With Accessories

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·O.P.R. -55 SOFT CONTACT LENS

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD