The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Ahbd.
| Device ID | K822739 |
| 510k Number | K822739 |
| Device Name: | AHBD |
| Classification | Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| Applicant | GILFORD 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 | 1982-09-09 |
| Decision Date | 1982-10-18 |