The following data is part of a premarket notification filed by Medilab Corp. with the FDA for Lyse-tec.
| Device ID | K840289 |
| 510k Number | K840289 |
| Device Name: | LYSE-TEC |
| Classification | Products, Red-cell Lysing Products |
| Applicant | MEDILAB CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-05 |