The following data is part of a premarket notification filed by Quidel Cardiovascular Inc. with the FDA for Quidel Triage® Tox Drug Screen, 94600.
| Device ID | K200363 |
| 510k Number | K200363 |
| Device Name: | Quidel Triage® TOX Drug Screen, 94600 |
| 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 | LAF |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-14 |
| Decision Date | 2020-03-11 |