The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Cr3 Keyless Split Sample Cup Amphetamine-cocaine.
Device ID | K141532 |
510k Number | K141532 |
Device Name: | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
Contact | Joe Shia |
Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
Product Code | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-10 |
Decision Date | 2014-07-14 |
Summary: | summary |