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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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11 records meeting your search criteria returned- Product Code: LTJ Report Date From: 1/1/2019 Report Date To: 12/31/2019
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ManufacturerBrand NameDate Report Received
SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTIG 11/27/2019
ABBOTT IRELAND ARCHITECT TOTAL PSA 08/16/2019
ABBOTT IRELAND ARCHITECT TOTAL PSA 07/23/2019
ABBOTT IRELAND ARCHITECT TOTAL PSA 07/18/2019
ABBOTT IRELAND ARCHITECT TOTAL PSA 06/28/2019
ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REA 04/22/2019
ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REA 04/22/2019
ABBOTT IRELAND ARCHITECT TOTAL PSA 03/20/2019
BIOMERIEUX SA VIDAS® TPSA 01/24/2019
BIOMERIEUX SA VIDAS® TPSA 01/24/2019
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