The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Total Bilirubin Test.
| Device ID | K811881 |
| 510k Number | K811881 |
| Device Name: | KING DIAGNOSTICS TOTAL BILIRUBIN TEST |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | KING DIAGNOSTICS, INC. 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 | 1981-07-01 |
| Decision Date | 1981-07-23 |