The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem Ldh-p Reagent W/separate Start-.
| Device ID | K831419 |
| 510k Number | K831419 |
| Device Name: | RAICHEM LDH-P REAGENT W/SEPARATE START- |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | REAGENTS APPLICATIONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-03 |
| Decision Date | 1983-06-16 |