Radioimmunoassay, Digitoxin (125-i)

Device Code: 6202

Product Code(s): LCW

Device Classification Information

Device Type ID6202
Device NameRadioimmunoassay, Digitoxin (125-i)
Regulation DescriptionDigitoxin Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLCW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID6202
DeviceRadioimmunoassay, Digitoxin (125-i)
Product CodeLCW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDigitoxin Test System.
CFR Regulation Number862.3300 [🔎]
TPLC Last Update: 2019-04-02 21:18:43

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