Plates, Ouchterlony Agar

Device Code: 3015

Product Code(s): JZP

Device Classification Information

Device Type ID3015
Device NamePlates, Ouchterlony Agar
Regulation DescriptionOuchterlony Agar Plate.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.4600 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeJZP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3015
DevicePlates, Ouchterlony Agar
Product CodeJZP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOuchterlony Agar Plate.
CFR Regulation Number866.4600 [🔎]
TPLC Last Update: 2019-04-02 20:22:38

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