The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Lactate Dehydrogenase Reagent.
| Device ID | K924965 |
| 510k Number | K924965 |
| Device Name: | OLYMPUS LACTATE DEHYDROGENASE REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1992-11-16 |