The following data is part of a premarket notification filed by Chemtron Biotech, Inc. with the FDA for Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests.
| Device ID | K102203 |
| 510k Number | K102203 |
| Device Name: | CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | 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 | 2010-08-04 |
| Decision Date | 2011-01-20 |
| Summary: | summary |