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.
Device ID | K971841 |
510k Number | K971841 |
Device Name: | BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST |
Classification | Enzyme Immunoassay, Cannabinoids |
Applicant | BIONIKE LABORATORIES, INC. 1015 GRANDVIEW DR. South San Francisco, CA 94080 -4910 |
Contact | Janis Freestone |
Correspondent | Janis Freestone BIONIKE LABORATORIES, INC. 1015 GRANDVIEW DR. South San Francisco, CA 94080 -4910 |
Product Code | LDJ |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-19 |
Decision Date | 1997-06-25 |