The following data is part of a premarket notification filed by Nippon Kogaku, Inc. with the FDA for Nikon Urine Refractomer Sg-1.
| Device ID | K802959 |
| 510k Number | K802959 |
| Device Name: | NIKON URINE REFRACTOMER SG-1 |
| Classification | Refractometer For Clinical Use |
| Applicant | NIPPON KOGAKU, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JRE |
| CFR Regulation Number | 862.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-20 |
| Decision Date | 1980-12-19 |