FDA 510(k) Applications Submitted by ERICA CONWAY

FDA 510(k) Number Submission Date Device Name Applicant
K062467 08/24/2006 AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 AXIS-SHIELD DIAGNOSTICS, LTD.
K063347 11/06/2006 AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 AXIS-SHIELD DIAGNOSTICS, LTD.


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