The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Modification To The Emit Ii Plus Cocaine Metabolite Assay.
| Device ID | K011162 |
| 510k Number | K011162 |
| Device Name: | MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Contact | Susan Collins |
| Correspondent | Susan Collins SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-05-02 |