The following data is part of a premarket notification filed by Harleco with the FDA for Unipak Total & Direct Bilirubin.
| Device ID | K771092 |
| 510k Number | K771092 |
| Device Name: | UNIPAK TOTAL & DIRECT BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | HARLECO 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-06-16 |
| Decision Date | 1977-07-21 |