WOUNDCHEK Bacterial Status

FDA 510(k)

FDA Class 2 ·Microbiology

BINAXNOW PBP2A TEST, MODEL 890-000

FDA 510(k)

FDA Class 2 ·Microbiology

VAULT ALIF SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPINAL USA VBR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PEAK FLOW MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY