The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Online Dat Benzodiazepines Plus.
| Device ID | K043327 |
| 510k Number | K043327 |
| Device Name: | ONLINE DAT BENZODIAZEPINES PLUS |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| 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 | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336170502 | K043327 | 000 |