The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue Drug Screen Cup Tests And Chemtrue Drug Screen Cup Tests With Opi 2000.
| Device ID | K143599 |
| 510k Number | K143599 |
| Device Name: | Chemtrue Drug Screen Cup Tests And Chemtrue Drug Screen Cup Tests With OPI 2000 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Chemtron Biotech, Inc. 9245 Brown Deer Road San Diego, CA 92121 |
| Contact | Jane Zhang |
| Correspondent | Jane Zhang Chemtron Biotech, Inc. 9245 Brown Deer Road San Diego, CA 92121 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-04-17 |
| Summary: | summary |