The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Amphetamine Urine Test (amp 300), Wondfo Methamphetamine Urine Test (met 500).
Device ID | K122961 |
510k Number | K122961 |
Device Name: | WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg, MD 20877 |
Contact | Joe Shia |
Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg, MD 20877 |
Product Code | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-25 |
Decision Date | 2012-12-21 |
Summary: | summary |