The following data is part of a premarket notification filed by Quest Diagnostics Incorporated with the FDA for Quest Diagnostics Haircheck-dt (cocaine).
| Device ID | K152232 |
| 510k Number | K152232 |
| Device Name: | Quest Diagnostics HairCheck-DT (Cocaine) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Quest Diagnostics Incorporated 10101 Renner Blvd. Lenexa, KS 66219 -9275 |
| Contact | Lisa Christo |
| Correspondent | Lisa Christo Quest Diagnostics Incorporated 10101 Renner Blvd. Lenexa, KS 66219 -9275 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868586000216 | K152232 | 000 |