Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE 11

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

NextDent Denture, E-Denture

FDA 510(k)

FDA Class 2 ·Dental

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM

FDA 510(k)

FDA Class 2 ·Dental

MEDRAD SPECTRIS MR INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD QWIK-FIX MRI DISPOSABLE KIT

FDA 510(k)

FDA Class 2 ·Radiology

BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNODIFFUSSION REAGENTS/SEROLOGICAL

FDA 510(k)

FDA Class 2 ·Microbiology

BLASTOMYCES DERMATITIDIS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

FERRITIN IMMUNORADIOMETRIC ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Antigen, Cf, B. Dermatitidis

FDA classification

FDA Class 2 ·Antigen, Cf, B. Dermatitidis

PRORAD X-Ray Flat Panel Detector with DROC

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Genotyping, Hepatitis C Virus

FDA classification

FDA Class 2 ·Assay, Genotyping, Hepatitis C Virus

MERCURY RHINOMANOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

VISIONAIR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology