The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue Single/multi-panel Drug Screen Cassette/dipcard.
| Device ID | K111322 |
| 510k Number | K111322 |
| Device Name: | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | CHEMTRON BIOTECH, INC. 8370 JUNIPER CREEK LANE SUITE 1-2 San Diego, CA 92126 |
| Contact | Jane Zhang |
| Correspondent | Jane Zhang CHEMTRON BIOTECH, INC. 8370 JUNIPER CREEK LANE SUITE 1-2 San Diego, CA 92126 |
| Product Code | JXM |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2011-09-14 |
| Summary: | summary |