UCP Drug Test Mini Cups

Enzyme Immunoassay, Amphetamine

UCP BIOSCIENCES, INC

The following data is part of a premarket notification filed by Ucp Biosciences, Inc with the FDA for Ucp Drug Test Mini Cups.

Pre-market Notification Details

Device IDK151213
510k NumberK151213
Device Name:UCP Drug Test Mini Cups
ClassificationEnzyme Immunoassay, Amphetamine
Applicant UCP BIOSCIENCES, INC 1445 KOLL CIRCLE, STE 111 San Jose,  CA  95112
ContactNancy Chen
CorrespondentNancy Chen
UCP BIOSCIENCES, INC 1445 KOLL CIRCLE, STE 111 San Jose,  CA  95112
Product CodeDKZ  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDJC
Subsequent Product CodeDJG
Subsequent Product CodeDJR
Subsequent Product CodeJXM
Subsequent Product CodeJXN
Subsequent Product CodeLCM
Subsequent Product CodeLDJ
Subsequent Product CodeLFG
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-06
Decision Date2015-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20817038021938 K151213 000
20817038022102 K151213 000
20817038022089 K151213 000
20817038020733 K151213 000
20817038020740 K151213 000
20817038020757 K151213 000
20817038020764 K151213 000
20817038021082 K151213 000
20817038021747 K151213 000
20817038021778 K151213 000
20817038022201 K151213 000

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