The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit Ii Plus Cocaine Metabolite Assay.
| Device ID | K031512 |
| 510k Number | K031512 |
| Device Name: | EMIT II PLUS COCAINE METABOLITE ASSAY |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-14 |
| Decision Date | 2003-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596082 | K031512 | 000 |
| 00630414568775 | K031512 | 000 |