Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

Meprobamate Test System

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Carisoprodol Metabolite / Meprobamate Urine Heia.

Pre-market Notification Details

Device IDK190397
501k NumberK190397
Device Name:Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
ClassificationMeprobamate Test System
Applicant Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
ContactYang Yang
CorrespondentYang Yang
Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
Product CodeQBK  
CFR Regulation Number862.3590 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyToxicology
501k Review PanelToxicology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-19
Decision Date2019-11-15

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