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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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