SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

HL-1 SUPPLEMENT

FDA 510(k)

FDA Class 1 ·Hematology

VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTREX COATED TUBE TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DOCUMENT R AMMONIA/ETHANOL CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MICRO H2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ID NOW Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX COATED TUBE INTACT PTH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE Anemia Calibration Verification/ Linearity Test Kit

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Prapela SVS hospital bassinet pad (model P01)

FDA 510(k)

SPQ(TM) ANTIBODY REAGENT SET II FOR IGA

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST

FDA 510(k)

FDA Class 1 ·Microbiology

BioFire RP2.1/RP2.1plus Control Panel M441

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Puritan Fecal Opti-Swab Collection and Transport System

FDA 510(k)

FDA Class 1 ·Microbiology