The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrazyme Plus Hbd.
| Device ID | K821877 |
| 510k Number | K821877 |
| Device Name: | ULTRAZYME PLUS HBD |
| Classification | Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| Applicant | HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JMK |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-25 |
| Decision Date | 1982-07-14 |