The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Mono-poly Resolving Medium.
| Device ID | K812947 |
| 510k Number | K812947 |
| Device Name: | MONO-POLY RESOLVING MEDIUM |
| Classification | Lymphocyte Separation Medium |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-20 |
| Decision Date | 1982-03-11 |