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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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