FDA 510(k) Applications for Medical Device Product Code "JWX"
(Kit, Screening, Staphylococcus Aureus)

FDA 510(k) Number Applicant Device Name Decision Date
K090964 BINAX, INC. BINAXNOX STAPHYLOCOCCUS AUREUS TEST 12/16/2009
K972030 OXOID, LTD. STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS 09/08/1997
K964315 REMEL, L.P. REMEL STAPH LATEX KIT 02/07/1997


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