The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Tri-level Bilirubin Controls.
| Device ID | K833898 |
| 510k Number | K833898 |
| Device Name: | TRI-LEVEL BILIRUBIN CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-14 |
| Decision Date | 1984-01-13 |