The following data is part of a premarket notification filed by Tianjin New Bay Bioresearch Co., Ltd. with the FDA for Forsure Rapid One Step Multiple(x) Abuse Drug Screen Test Cup Device.
| Device ID | K052882 |
| 510k Number | K052882 |
| Device Name: | FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Contact | Rodrigo Berlie |
| Correspondent | Rodrigo Berlie Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFH |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-12 |
| Decision Date | 2006-02-15 |
| Summary: | summary |