The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondofo Multi-drug Urine Test Cup / Panel.
| Device ID | K130665 |
| 510k Number | K130665 |
| Device Name: | WONDOFO MULTI-DRUG URINE TEST CUP / PANEL |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816862025040 | K130665 | 000 |
| 10816862020011 | K130665 | 000 |
| 10816862020028 | K130665 | 000 |
| 10816862020035 | K130665 | 000 |
| 10816862020042 | K130665 | 000 |
| 00816862025002 | K130665 | 000 |
| 00816862025019 | K130665 | 000 |
| 00816862025026 | K130665 | 000 |
| 00816862025033 | K130665 | 000 |
| 10816862020004 | K130665 | 000 |