The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Dat Barbiturates Plus.
| Device ID | K043211 |
| 510k Number | K043211 |
| Device Name: | ONLINE DAT BARBITURATES PLUS |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-19 |
| Decision Date | 2004-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121030 | K043211 | 000 |