IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

H-103 IGG, H-104 IGA, H-105 IGM

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

AUTOMATED IMMUNOPRECIPITIN METHOD/ICG

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO RABBIT IMMUNOGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGG ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERA TO RABBIT IMMUNOGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·VOYAGER OTW CORONARY DILATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·RX CHASSIS 3 CORONARY DILATATION CATHETER

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·HIGHSAIL CORONARY DILATATION CATHETERS

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MTS Doxycycline 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology