The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Methadone Urine Test (mtd 200), Wondofo Morphine Urine Test (mop 100).
Device ID | K131232 |
510k Number | K131232 |
Device Name: | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) |
Classification | Enzyme Immunoassay, Methadone |
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 | DJR |
CFR Regulation Number | 862.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-01 |
Decision Date | 2013-05-31 |
Summary: | summary |