The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Bilirubin Assay Kit Direct.
| Device ID | K843027 |
| 510k Number | K843027 |
| Device Name: | BILIRUBIN ASSAY KIT DIRECT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-01 |
| Decision Date | 1984-09-04 |