The following data is part of a premarket notification filed by Biosan Laboratories, Inc. with the FDA for Bio-rex 70 Resin 100-200 Mesh Ph6.2.
| Device ID | K833319 |
| 510k Number | K833319 |
| Device Name: | BIO-REX 70 RESIN 100-200 MESH PH6.2 |
| Classification | Resins, Ion-exchange |
| Applicant | BIOSAN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEA |
| CFR Regulation Number | 862.2230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-26 |
| Decision Date | 1983-11-03 |