The following data is part of a premarket notification filed by Quest Diagnostics, Inc. with the FDA for Aml Haircheck-dt (cocaine).
| Device ID | K023626 |
| 510k Number | K023626 |
| Device Name: | AML HAIRCHECK-DT (COCAINE) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-29 |
| Decision Date | 2003-09-29 |