The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Uric Acid Standard, 8mg/dl #65078.
| Device ID | K823147 |
| 510k Number | K823147 |
| Device Name: | URIC ACID STANDARD, 8MG/DL #65078 |
| Classification | Calibrator, Primary |
| Applicant | HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-25 |
| Decision Date | 1982-11-22 |