The following data is part of a premarket notification filed by Quidel Cardiovascular Inc. with the FDA for Quidel Triage Tox Drug Screen, 94600; Quidel Triage® Meterpro.
| Device ID | K182719 |
| 510k Number | K182719 |
| Device Name: | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 |
| Contact | Rachael S. Williamson |
| Correspondent | Rachael S. Williamson Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 |
| Product Code | DKZ |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXO |
| Subsequent Product Code | KHO |
| Subsequent Product Code | LAF |
| 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 | 2018-09-28 |
| Decision Date | 2019-06-19 |