The following data is part of a premarket notification filed by Harleco with the FDA for Qualitrol #65057.
| Device ID | K810725 |
| 510k Number | K810725 |
| Device Name: | QUALITROL #65057 |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-17 |
| Decision Date | 1981-03-31 |