Current Health Monitoring System Gen 2 (G2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Selux AST System; Model AST Gen 1.0

FDA 510(k)

FDA Class 2 ·Microbiology

WSA Self-Fitting Hearing Aid Gen 2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

G-FORCE GEN 2 SUTURE ANCHOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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)

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)

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)

VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CEDIA(R) FOLATE (NO BOIL) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS RED BLOOD CELL FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOLID PHASE SIMUL TRAC VITAMIN B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CIBA CORNING ACS FOLATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NO-BOIL FOLATE KIT #RP-500

FDA 510(k)

FDA Class 2 ·Clinical Chemistry