The following data is part of a premarket notification filed by Drial Consultants, Inc. with the FDA for Quikstrip One Step Methamphetamine.
Device ID | K970395 |
510k Number | K970395 |
Device Name: | QUIKSTRIP ONE STEP METHAMPHETAMINE |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | DRIAL CONSULTANTS, INC. 1420 LOS ANGELES AVE. STE 201 Simi Valley, CA 93065 |
Contact | Cleve Laird |
Correspondent | Cleve Laird DRIAL CONSULTANTS, INC. 1420 LOS ANGELES AVE. STE 201 Simi Valley, CA 93065 |
Product Code | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-03 |
Decision Date | 1997-06-26 |
Summary: | summary |