The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Creatinine Reagent.
| Device ID | K924692 |
| 510k Number | K924692 |
| Device Name: | OLYMPUS CREATININE REAGENT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| 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 | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-17 |
| Decision Date | 1992-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590060077 | K924692 | 000 |
| 15099590010737 | K924692 | 000 |