Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Enzyme Immunoassay, Benzodiazepine

IMMUNALYSIS CORPORATION

The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-drug Calibrators.

Pre-market Notification Details

Device IDK151771
510k NumberK151771
Device Name:Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
ClassificationEnzyme Immunoassay, Benzodiazepine
Applicant IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR Pomona,  CA  91767
ContactJoseph Ginete
CorrespondentJoseph Ginete
IMMUNALYSIS CORPORATION 829 TOWNE CENTER DR Pomona,  CA  91767
Product CodeJXM  
CFR Regulation Number862.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-30
Decision Date2016-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840937102138 K151771 000
00840937102114 K151771 000
00840937102091 K151771 000
00840937102077 K151771 000

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