SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT

FDA 510(k)

FDA Class 2 ·General Hospital

QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

OHMEDA INOVENT DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

AHIP INTERNAL TRIGGER POINT WAND MODEL: 1

FDA 510(k)

FDA Class 2 ·Physical Medicine

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

COMPUTERIZED LABOR MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

RETROX

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HEM-AVERT PERIANAL STABILIZER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NUCLEUS-X PTV CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND

FDA 510(k)

FDA Class 2 ·Neurology

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

DIAMOND PROBE/PERIO 2000 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

THROMBOPLASTIN

FDA 510(k)

FDA Class 2 ·Hematology

APTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology