FDA 510(k) Applications Submitted by Tina Sobania

FDA 510(k) Number Submission Date Device Name Applicant
K190086 01/17/2019 Cepheid Xpert Respiratory Control Panel Microbiologics, Inc.
K190223 02/05/2019 Cepheid Xpert CT/NG Control Panel Microbiologics, Inc.
K190463 02/26/2019 Cepheid Xpert C. difficile/Epi Control Panel Microbiologics, Inc.
K191168 05/01/2019 Cepheid Xpert SA Nasal Complete Control Panel Microbiologics, Inc.
K191172 05/01/2019 Cepheid Xpert MRSA NxG Control Panel Microbiologics, Inc.
K181683 06/26/2018 BD MAX CT/GC/TV 20-Day QC Panel Microbiologics, Inc.
K181711 06/28/2018 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel Microbiologics, Inc.
K182472 09/10/2018 Cepheid Xpert GBS LB Control Panel Microbiologics, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact