Kit, Culture, Chromosome

Device Code: 4838

Product Code(s): KIQ

Device Classification Information

Device Type ID4838
Device NameKit, Culture, Chromosome
Regulation DescriptionChromosome Culture Kit.
Regulation Medical SpecialtyHematology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.2260 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKIQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4838
DeviceKit, Culture, Chromosome
Product CodeKIQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionChromosome Culture Kit.
CFR Regulation Number864.2260 [🔎]
TPLC Last Update: 2019-04-02 20:56:17

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