The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Aspartate Aminotransferase Reagent.
| Device ID | K925155 |
| 510k Number | K925155 |
| Device Name: | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| 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 | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590060039 | K925155 | 000 |
| 15099590050085 | K925155 | 000 |
| 15099590020026 | K925155 | 000 |
| 15099590010089 | K925155 | 000 |