The following data is part of a premarket notification filed by Labone, Inc. with the FDA for Labone Cocaine Metabolite Micro-plate Eia.
| Device ID | K040198 |
| 510k Number | K040198 |
| Device Name: | LABONE COCAINE METABOLITE MICRO-PLATE EIA |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | LABONE, INC. 10101 RENNER BLVD. Lenexa, KS 66219 |
| Contact | Liuming Yu |
| Correspondent | Laura L Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2004-03-05 |
| Summary: | summary |