The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra-1000 Sys, Direct Bilirubin.
| Device ID | K842809 |
| 510k Number | K842809 |
| Device Name: | TECHNICON RA-1000 SYS, DIRECT BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | TECHNICON INSTRUMENTS CORP. 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 | 1984-07-18 |
| Decision Date | 1984-08-17 |