NuEra Tight, NuEra Tight EMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VARIANT(TM) HEMOGLOBIN A 1C PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PLATELIA LYME IGM

FDA 510(k)

FDA Class 2 ·Microbiology

LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204

FDA 510(k)

FDA Class 2 ·Immunology

PROCEDURE, RA, THYROXINE BINDING PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLUOROMATIC PHENOLBARBITAL FIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VARIANT II HEMOGLOBIN A1C PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER

FDA 510(k)

FDA Class 2 ·Hematology

RADIAS ANA SCREEN ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS

FDA 510(k)

FDA Class 2 ·Microbiology

LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783

FDA 510(k)

FDA Class 2 ·Hematology

QUANTAPHASE II B12/FOLATE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116

FDA 510(k)

FDA Class 2 ·Immunology

TEST, RIA, TSH QUANTIMUNE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIANT TOTAL GHB PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

TIP & MEMBRANE ASSEMBLY

FDA 510(k)

FDA Class 2 ·Ophthalmic

LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201

FDA 510(k)

FDA Class 2 ·Immunology

APL MEDICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery