The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Serum @-hydroxybutyrate Dehydrogenase (hbdh).
| Device ID | K941427 |
| 510k Number | K941427 |
| Device Name: | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) |
| Classification | Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | K.c. Chen |
| Correspondent | K.c. Chen TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | JMK |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1995-03-13 |