The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Total Bilirubin Reagent.
| Device ID | K901266 |
| 510k Number | K901266 |
| Device Name: | COULTER TOTAL BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | A Richardson-jones |
| Correspondent | A Richardson-jones COULTER CORP. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-16 |
| Decision Date | 1990-04-25 |