ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

X-AMYLASE ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CATALOGUE NUMBER 321-07/15/50

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DC-UIBC-CO2-CAL, MODEL SE-153

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DC-3 FLUIDS PACK, DC-5 FLUIDS PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CK-MB ASSAY, CATALOGUE NUMBER 317-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

FDA classification

FDA Class 2 ·Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Analyzer, Medical Image

FDA classification

FDA Class 2 ·Analyzer, Medical Image

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS