LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL

FDA 510(k)

FDA Class 2 ·Orthopedic

COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON

FDA 510(k)

FDA Class 2 ·Orthopedic

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)

FDA 510(k)

FDA Class 2 ·Anesthesiology

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)

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)

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)

CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lunoa System

FDA 510(k)

FDA Class 2 ·Dental