BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST

Enzyme Immunoassay, Cannabinoids

BIONIKE LABORATORIES, INC.

The following data is part of a premarket notification filed by Bionike Laboratories, Inc. with the FDA for Bionike Aq One Step Cannabinoids (thc) Test.

Pre-market Notification Details

Device IDK971841
510k NumberK971841
Device Name:BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant BIONIKE LABORATORIES, INC. 1015 GRANDVIEW DR. South San Francisco,  CA  94080 -4910
ContactJanis Freestone
CorrespondentJanis Freestone
BIONIKE LABORATORIES, INC. 1015 GRANDVIEW DR. South San Francisco,  CA  94080 -4910
Product CodeLDJ  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-19
Decision Date1997-06-25

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