The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Hbdh (optimized) Reagent.
| Device ID | K862319 |
| 510k Number | K862319 |
| Device Name: | HBDH (OPTIMIZED) REAGENT |
| Classification | Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | JMK |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-18 |
| Decision Date | 1986-07-07 |