FDA 510(k) Applications for Medical Device Product Code "OAM"
(Immunoassay, Insulin-Like Growth Factor Binding Protein-1)

FDA 510(k) Number Applicant Device Name Decision Date
K123986 ALERE SCARBOROUGH, INC ACTIM PROM 01/09/2014
K061886 MEDIX BIOCHEMICA ACTIM PROM AND CONTROLS 01/25/2007


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