FDA 510(k) Applications for Medical Device Product Code "MSW"
(System,Test,Thyroglobulin)

FDA 510(k) Number Applicant Device Name Decision Date
K220972 Beckman Coulter, Inc Access Thyroglobulin 09/15/2023
K002905 BECKMAN COULTER, INC. ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER 10/19/2000
K031269 BECKMAN COULTER, INC. ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS 05/02/2003
K021057 BRAHMS DIAGNOSTICA, LLC. BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS 09/17/2002
K982468 DIAGNOSTIC PRODUCTS CORP. IMMULITE 2000 THYROGLOBULIN MODEL L2KTY 03/12/1999
K982466 DIAGNOSTIC PRODUCTS CORP. IMMULITE THYROGLOBULIN MODEL LKTY 03/12/1999
K002888 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE THYROGLOB 10/20/2000
K994140 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 05/09/2000
K221890 Roche Diagnostics Elecsys Tg II 09/30/2023
K991720 UNCHANGED KRONUS OPTIQUANT THYROGLOBULIN KIT 08/09/1999


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