The following data is part of a premarket notification filed by Kyoto Diagnostics, Inc. with the FDA for Atago Urine Specific Gravity & Serum.
| Device ID | K842168 |
| 510k Number | K842168 |
| Device Name: | ATAGO URINE SPECIFIC GRAVITY & SERUM |
| Classification | Refractometer For Clinical Use |
| Applicant | KYOTO DIAGNOSTICS, 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 | 1984-05-31 |
| Decision Date | 1984-07-16 |