The following data is part of a premarket notification filed by Quest Diagnostics, Inc. with the FDA for Quest Diagnostics Urine Cocaine Metabolite Eia.
| Device ID | K062929 |
| 510k Number | K062929 |
| Device Name: | QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | QUEST DIAGNOSTICS, INC. 10101 RENNER BLVD. Lenexa, KS 66219 -9752 |
| Contact | Liuming Yu |
| Correspondent | Liuming Yu QUEST DIAGNOSTICS, INC. 10101 RENNER BLVD. Lenexa, KS 66219 -9752 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-12-18 |
| Summary: | summary |