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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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18 records meeting your search criteria returned- Product Code: JHX Product Problem: High Test Results Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
QUIDEL CARDIOVASCULAR, INC. KIT, TRIAGE, CARDIAC TNI/CKMB 03/23/2018
QUIDEL CARDIOVASCULAR, INC. TRIAGE CARDIAC TRIPLE MARKER PANEL 02/05/2018
ABBOTT LABORATORIES ARCHITECT STAT CK-MB 01/18/2018
ABBOTT LABORATORIES ARCHITECT STAT CK-MB 05/16/2016
ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB R 04/21/2016
ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB R 04/21/2016
ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CKMB SLIDES 03/07/2016
ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB R 01/20/2016
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