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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: JIT Applicant: AXIS-SHIELD DIAGNOSTICS, LTD. Decision Date To: 06/10/2024
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architect hba1c, architect hba1c, and architect hba1c AXIS-SHIELD DIAGNOSTICS, LTD. K121842 12/12/2012
architect active b-12 (holotranscobalamin) AXIS-SHIELD DIAGNOSTICS, LTD. K112443 12/19/2011
axis-shield liquid stable (ls) 2-part homocysteine reagent, model fhrk100 AXIS-SHIELD DIAGNOSTICS, LTD. K083222 07/31/2009
architect homocysteine reagents, calibrators and controls AXIS-SHIELD DIAGNOSTICS, LTD. K073640 04/24/2008
axsym hba1c reagents, axsym hba1c calibrators, axsym hba1c controls AXIS-SHIELD DIAGNOSTICS, LTD. K072686 03/17/2008
axsym holo tc reagent kit, model 3l83-20; standard calibrator kit, model 3l83-01; control kit, model 3l83-10 AXIS-SHIELD DIAGNOSTICS, LTD. K062467 11/22/2006
abbott axsym b-type natriuretic peptide (bnp) microparticle enzyme immunoassay (meia) test AXIS-SHIELD DIAGNOSTICS, LTD. K033606 01/30/2004
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