FDA 510(k) Applications for Medical Device Product Code "NQM"
(Immunoassay, Placental Alpha-1 Microglobulin (Pamg-1))

FDA 510(k) Number Applicant Device Name Decision Date
K081767 AMNISURE INTERNATIONAL, LLC AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 01/09/2009
K110605 CLINICAL INNOVATIONS, LLC ROM PLUS 11/23/2011


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