Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur and Atellica IM HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHTECT ANTI-HCV

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP

FDA 510(k)

FDA Class 2 ·Orthopedic

FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY

FDA 510(k)

FDA Class 2 ·Orthopedic

ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component

FDA 510(k)

FDA Class 2 ·Orthopedic

ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E

FDA 510(k)

FDA Class 2 ·Dental

HISTOPLASMA YEAST ANTI #CF10021X

FDA 510(k)

FDA Class 2 ·Microbiology

FUNGAL IMMUNODIFFUSION KIT #ID1001

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOPLASMA CAPSULATUM, ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOPLASMA YEAST ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOPLASMA CAPSULATUM, ANTIGEN YEAST

FDA 510(k)

FDA Class 2 ·Microbiology

LA-HISTO ANTIBODY SYSTEM #HL 1001

FDA 510(k)

FDA Class 2 ·Microbiology

LEPTOSPIROSIS IHA

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOPLASMA MYCELIAL ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

HISTOPLASMA MYCELIAL #CF10020X

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNO. IDENTIFICATION OF H. CAPSULATUM

FDA 510(k)

FDA Class 2 ·Microbiology