The following data is part of a premarket notification filed by Tianjin New Bay Bioresearch Co., Ltd. with the FDA for Rapid Forsure One Step Multiple Drug (up To 6) Screen Test Device For Amphetamine, Methamphetamine, Benzoylecgonine, Thc.
| Device ID | K052520 |
| 510k Number | K052520 |
| Device Name: | RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DPK |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2006-04-24 |
| Summary: | summary |