The following data is part of a premarket notification filed by Quest Diagnostics, Inc. with the FDA for Quest Diagnostics Haircheck-dt (opiates).
| Device ID | K042725 |
| 510k Number | K042725 |
| Device Name: | QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | QUEST DIAGNOSTICS, INC. 4230 BURNHAM AVE. Las Vegas, NV 89119 -5410 |
| Contact | James A Bourland |
| Correspondent | James A Bourland QUEST DIAGNOSTICS, INC. 4230 BURNHAM AVE. Las Vegas, NV 89119 -5410 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-01 |
| Decision Date | 2005-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868586000223 | K042725 | 000 |