The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Dat Ii Cocaine Ii.
| Device ID | K023281 |
| 510k Number | K023281 |
| Device Name: | ONLINE DAT II COCAINE II |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-01 |
| Decision Date | 2002-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121153 | K023281 | 000 |
| 04015630996506 | K023281 | 000 |