The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue Bup/tca Single/multi-panel Drug Screen Dip Card/cup/cassette Tests.
| Device ID | K142396 |
| 510k Number | K142396 |
| Device Name: | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests |
| 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 |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2014-10-09 |
| Summary: | summary |