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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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