Monitor, Microbial Growth

Device Code: 3356

Product Code(s): JTA

Device Classification Information

Device Type ID3356
Device NameMonitor, Microbial Growth
Regulation DescriptionMicrobial Growth Monitor.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.2560 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJTA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3356
DeviceMonitor, Microbial Growth
Product CodeJTA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMicrobial Growth Monitor.
CFR Regulation Number866.2560 [🔎]
TPLC Last Update: 2019-04-02 20:28:08

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