FDA 510(k) Applications Submitted by FUTOSHI INOUE

FDA 510(k) Number Submission Date Device Name Applicant
K160142 01/21/2016 MINERAL OIL KITAZATO BIOPHARMA CO., LTD.
K200249 02/03/2020 Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) Kitazato Corporation
K190199 02/04/2019 SepaSperm Washing Solution, SepaSperm Solution Kitazato Corporation
K160863 03/29/2016 PBS(-), Phosphate Buffered Saline KITAZATO BIOPHARMA CO., LTD.
K160864 03/29/2016 Cryotop Vitrification Kit and Cryotop Thawing Kit KITAZATO BIOPHARMA CO., LTD.
K181469 06/04/2018 Cryotop«US-flash and Cryotop«US-scoop Kitazato Corporation
K171748 06/13/2017 Vitrification Kit and Thawing Kit Kitazato Corporation
K182002 07/26/2018 Cumulus Remover Kitazato Corporation
K192540 09/16/2019 Kitazato ET Catheters Kitazato Corporation
K192845 10/03/2019 Sperm Freeze, Sperm Fridge Kitazato Corporation
K153027 10/16/2015 Cryotop US KITAZATO BIOPHARMA CO., LTD.
K193522 12/19/2019 iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA Kitazato Corporation


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