FDA 510(k) Applications Submitted by JUDITH E LOEBEL

FDA 510(k) Number Submission Date Device Name Applicant
K990431 02/11/1999 AIA-PACK CA 125 TOSOH MEDICS, INC.
K131928 06/27/2013 FREND TSH (REAGENT CARTRIDGE) NANOEN TEK USA, INC.
K992365 07/15/1999 AIA-PACK FOLATE ASSAY TOSOH MEDICS, INC.
K023239 09/27/2002 AIA-PACK CA 19-9 TOSOH CORP.
K023240 09/27/2002 ST AIA-PACK CA 19-9 TOSOH CORP.
K124056 12/31/2012 FREND PSA PLUS (REAGENT CARTRIDGE) NANOEN TEK, INC.


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