The following data is part of a premarket notification filed by Rapid Diagnostics, Inc. with the FDA for Micromedic Drugs Of Abuse Panel Test (9), Catalog Number 07rd-7062.
| Device ID | K033566 |
| 510k Number | K033566 |
| Device Name: | MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | RAPID DIAGNOSTICS, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Contact | Robin J Hellen |
| Correspondent | Robin J Hellen RAPID DIAGNOSTICS, INC. 9418 LASAINE AVE. Northridge, CA 91325 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| 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 | 2003-11-12 |
| Decision Date | 2004-05-17 |