The following data is part of a premarket notification filed by Becton Dickinson Advanced Diagnostics with the FDA for Riatrac Plus.
| Device ID | K914958 |
| 510k Number | K914958 |
| Device Name: | RIATRAC PLUS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BECTON DICKINSON ADVANCED DIAGNOSTICS 225 INTERNATIONAL CIRCLE Cockeysville, MD 21030 |
| Contact | Lloyd W.gaedke |
| Correspondent | Lloyd W.gaedke BECTON DICKINSON ADVANCED DIAGNOSTICS 225 INTERNATIONAL CIRCLE Cockeysville, MD 21030 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-05 |
| Decision Date | 1992-03-18 |