The following data is part of a premarket notification filed by Accu-stat Diagnostics, Inc. with the FDA for Accu-stat Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, And Phencyclidine.
| Device ID | K040629 |
| 510k Number | K040629 |
| Device Name: | ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | MVO |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-10 |
| Decision Date | 2004-05-05 |
| Summary: | summary |