Device, Media Dispensing/stacking

Device Code: 3357

Product Code(s): JTB

Device Classification Information

Device Type ID3357
Device NameDevice, Media Dispensing/stacking
Regulation DescriptionAutomated Medium Dispensing And Stacking Device.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.2440 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJTB
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3357
DeviceDevice, Media Dispensing/stacking
Product CodeJTB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAutomated Medium Dispensing And Stacking Device.
CFR Regulation Number866.2440 [🔎]
TPLC Last Update: 2019-04-02 20:28:09

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.