FDA 510(k) Applications Submitted by Han Seul Kim

FDA 510(k) Number Submission Date Device Name Applicant
K210039 01/06/2021 CORE1 Implant System Cybermed Inc.
K001603 05/24/2000 REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) REPROMEDIX CORP.
K001606 05/24/2000 REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) REPROMEDIX CORP.
K001607 05/24/2000 REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) REPROMEDIX CORP.
K242847 09/20/2024 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi DRTECH Corporation


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