TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

AST/SGOT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYALLERGYTEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DONG BANG ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

C-76 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

POLYBONE GRANULE & BLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL PROTEIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

T-3 UPTAKE/RIASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Isocapnic Ventilation Device

FDA classification

FDA Class 2 ·Isocapnic Ventilation Device

Retrograde Intubation Set

FDA classification

FDA Class 2 ·Retrograde Intubation Set

Respirator, Surgical

FDA classification

FDA Class 2 ·Respirator, Surgical

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

FDA classification

FDA Class 2 ·Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

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