The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for One Step Multiple Drugs Of Abuse Assays.
| Device ID | K050024 |
| 510k Number | K050024 |
| Device Name: | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19087 |
| Contact | Howard K Mann |
| Correspondent | Howard K Mann Guangzhou Wondfo Biotech Co., Ltd. 8903 SPRUCE MILL DRIVE Yardley, PA 19087 |
| Product Code | DIS |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-05 |
| Decision Date | 2005-11-17 |
| Summary: | summary |