The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Tris Bicarbonate Diluent.
| Device ID | K760818 |
| 510k Number | K760818 |
| Device Name: | TRIS BICARBONATE DILUENT |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-12 |
| Decision Date | 1976-11-05 |