The following data is part of a premarket notification filed by Atlas Medical with the FDA for Atlas Multi-drugs Screening Test Cup, Atlas Multi-drugs Screening Test Panel.
| Device ID | K191099 |
| 510k Number | K191099 |
| Device Name: | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Atlas Medical King Abdullah Industrial Estate, Sahab Free Zone Area P.O Box 204 Amman, JO |
| Contact | Amani Al-habahbeh |
| 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 | DNK |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-25 |
| Decision Date | 2019-10-03 |