The following data is part of a premarket notification filed by Accu-stat Diagnostics, Inc. with the FDA for Accu-stat Home Drug Tests For Marijuana (thc) And For Marijuana & Cocaine (thc, Coc).
| Device ID | K040327 |
| 510k Number | K040327 |
| Device Name: | ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) |
| Classification | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Applicant | ACCU-STAT DIAGNOSTICS, INC. 11 ORCHARD RD., SUITE 108 Lake Forest, CA 92630 |
| Contact | James G Barrons |
| Correspondent | James G Barrons ACCU-STAT DIAGNOSTICS, INC. 11 ORCHARD RD., SUITE 108 Lake Forest, CA 92630 |
| Product Code | MVO |
| Subsequent Product Code | DIO |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-10 |
| Decision Date | 2004-04-19 |
| Summary: | summary |