The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem X-hbdh Reagent.
| Device ID | K843774 |
| 510k Number | K843774 |
| Device Name: | RAICHEM X-HBDH REAGENT |
| Classification | Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| Applicant | REAGENTS APPLICATIONS, INC. 7605 CONVOY COURT San Diego , CA 92111 - |
| Contact | Giovanni Bucolo |
| Correspondent | Giovanni Bucolo REAGENTS APPLICATIONS, INC. 7605 CONVOY COURT San Diego , CA 92111 - |
| Product Code | JMK |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-25 |
| Decision Date | 1984-10-31 |