MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FORTUNE SILICONE VACUUM SUCTION, MODEL #1300

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VITEK 2 STRPTOCOCCUS CEFTRIAXONE

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS B.R.A.H.M.S. PCT (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTACT II (POLYMACON)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTACT(TM) (DELTAFILCON A)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTACT II (POLYMACON)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTACT II (POLYMACON)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTACT II (POLYMACON)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTACT II (POLYMACON)