The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Ld-p Reagent (ldh P-l Reagent).
| Device ID | K790771 |
| 510k Number | K790771 |
| Device Name: | LD-P REAGENT (LDH P-L REAGENT) |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | GILFORD DIAGNOSTICS 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 | 1979-04-20 |
| Decision Date | 1979-05-15 |