Test, Occult Blood, Over The Counter

Device Code: 6014

Product Code(s): NGK

Device Classification Information

Device Type ID6014
Device NameTest, Occult Blood, Over The Counter
Regulation DescriptionOccult Blood Test.
Regulation Medical SpecialtyHematology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number864.6550 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNGK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6014
DeviceTest, Occult Blood, Over The Counter
Product CodeNGK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOccult Blood Test.
CFR Regulation Number864.6550 [🔎]
TPLC Last Update: 2019-04-02 21:16:04

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