Previous 501(k) submission and FDA approval dates: C. difficile - 11/14/2011 ~ 05/01/2012 - 169 days Group B Strep Assay - 11/19/2014 ~ 04/22/2015 - 154 days Pending assays for tomorrow (02/02/2016): Staph ID/R Blood Culture - 08/31/2015 ~ Current - 155 days and counting Shiga Toxin Direct - 10/08/2015 ~ Current - 117 days and counting FYI. Cheers!