Quantisal Oral Fluid Collection Device

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

Immunalysis Corporation

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Quantisal Oral Fluid Collection Device.

Pre-market Notification Details

Device IDK200801
510k NumberK200801
Device Name:Quantisal Oral Fluid Collection Device
ClassificationOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Applicant Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
ContactWenying (jessica) Zhu
CorrespondentWenying (jessica) Zhu
Immunalysis Corporation 829 Towne Center Drive Pomona,  CA  91767
Product CodePJD  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-27
Decision Date2020-07-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840937112168 K200801 000
00840937112151 K200801 000

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