The following data is part of a premarket notification filed by Quest Diagnostics, Inc. with the FDA for Quest Diagnostics Haircheck-dt (pcp.
| Device ID | K042726 |
| 510k Number | K042726 |
| Device Name: | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-01 |
| Decision Date | 2005-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868586000254 | K042726 | 000 |