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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: LPS Applicant: AXIS-SHIELD DIAGNOSTICS, LTD. Decision Date To: 05/31/2023
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axis-shield 3-reagent homocysteine assay for synchron AXIS-SHIELD DIAGNOSTICS, LTD. K112790 05/07/2012
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
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