The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Multi-drug Urine Test Cup Model W2002-cu; W2003-cu; W2004-cu; W2005-cu; W2006-cu; W2007-cu; W2008-cu; W2009-cu;.
| Device ID | K122904 |
| 510k Number | K122904 |
| Device Name: | WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersbrug, MD 20878 |
| Contact | Joe Shia |
| Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersbrug, MD 20878 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2012-11-15 |
| Summary: | summary |