The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue Single/multi-panel Drug Screen Dip Card/cassette Tests.
| Device ID | K121339 |
| 510k Number | K121339 |
| Device Name: | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | CHEMTRON BIOTECH, INC. 9245 Brown Deer Rd San Diego, CA 92121 |
| Contact | Jane Zhang |
| Correspondent | Jane Zhang CHEMTRON BIOTECH, INC. 9245 Brown Deer Rd San Diego, CA 92121 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DNK |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-03 |
| Decision Date | 2012-05-17 |
| Summary: | summary |