The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Poly-lec System.
| Device ID | K792582 |
| 510k Number | K792582 |
| Device Name: | POLY-LEC SYSTEM |
| Classification | Lectins And Protectins |
| Applicant | GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSI |
| CFR Regulation Number | 864.9550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-14 |
| Decision Date | 1980-01-16 |