510(k) Premarket Notification

510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA

New Search Back To Search Results Device Classification Name fluorometer, for clinical use 510(k) Number K890908 Device Name STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES Applicant BAXTER HEALTHCARE CORP. p.o. box 520672 miami,  FL  33152 Contact jeanne-marie varga Regulation Number 862.2560 Classification Product Code KHO   Date Received 02/23/1989 Decision Date 03/24/1989 Decision substantially equivalent (SE) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Type Traditional Reviewed by Third Party No Expedited Review