The following data is part of a premarket notification filed by Quest Diagnostics, Inc. with the FDA for Quest Diagnostics Haircheck-dt (thc).
| Device ID | K040257 |
| 510k Number | K040257 |
| Device Name: | QUEST DIAGNOSTICS HAIRCHECK-DT (THC) |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | QUEST DIAGNOSTICS, INC. 4230 BURNHAM AVE. Las Vegas, NV 89119 -5410 |
| Contact | Patrick Carpenter |
| Correspondent | Patrick Carpenter QUEST DIAGNOSTICS, INC. 4230 BURNHAM AVE. Las Vegas, NV 89119 -5410 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-04 |
| Decision Date | 2004-06-14 |