The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Ria Controls.
| Device ID | K781593 |
| 510k Number | K781593 |
| Device Name: | RIA CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-18 |
| Decision Date | 1978-10-17 |