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Data / Medical devices / South Korea / Boditech Med Inc.

Boditech Med Inc.: FDA-registered device maker in Chuncheon Gangwon, South Korea, 1 510(k) clearance

Boditech Med Inc. is registered with the FDA (registration 3009491259) in Chuncheon Gangwon, South Korea. It lists 23 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 13, 2017. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Boditech Med Inc.
FDA registration number
3009491259
Address
43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon Gangwon, South Korea, 24398
Owner or operator
Boditech Med Inc. (10046783)
Roles
Contract manufacturer, Manufacturer
First device listed
May 12, 2014
Registered through
2027
Brand names listed
AFIAS C-peptide, AFIAS Estradiol, AFIAS FSH, AFIAS IGF-1, AFIAS Insulin, AFIAS LH, AFIAS Microalbumin, AFIAS NORO and more

Devices it lists

DeviceProduct codeClassRoleSource
Albumin, Antigen, Antiserum, ControlDCF2Manufactureraccessdata.fda.gov
Antigen, Cf (Including Cf Controls), Respiratory Syncytial VirusGQG1Manufactureraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Manufactureraccessdata.fda.gov
Automated Occult Blood AnalyzerOOX2Contract manufactureraccessdata.fda.gov
Control, HemoglobinGGM2Contract manufactureraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Manufactureraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RotavirusLIQ1Manufactureraccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Manufactureraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufactureraccessdata.fda.gov
Norovirus Serological ReagentOUC2Manufactureraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Manufactureraccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Manufactureraccessdata.fda.gov
Radioimmunoassay, Human Growth HormoneCFL1Manufactureraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Manufactureraccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Manufactureraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Manufactureraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Manufactureraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Contract manufacturer, Manufactureraccessdata.fda.gov
System, Hemoglobin, AutomatedGKR2Contract manufactureraccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 13, 2017K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerJLWSubstantially EquivalentBoditech Med, Inc.accessdata.fda.gov

Compare with other makers

Updated October 13, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.