Could it be this? If it is then pay attention to Approval date
Device Classification Name tubes, vials, systems, serum separators, blood collection 510(k) Number K091292 Model 368771 Device Name BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 36877 Applicant BECTON DICKINSON AND COMPANY (BD) 1 becton drive. mc300 franklin lakes, NJ 07417 188
Contact mary ann alsberge Regulation Number 862.1675 Classification Product Code JKA
Date Received 05/04/2009 Decision Date 08/25/2009 Decision substantially equivalent (SE) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No
I looked through their web site, but didn't see the pr on filing. Could google the device and maybe get more info. This company stock trades around $68, so they have the $$ to get priority review and small frys have to wait and wait and wait.