The following data is part of a premarket notification filed by Icn Pharmaceuticals, Inc. with the FDA for Bilirubin Procedure, Tekpoint Tot & Dir..
| Device ID | K770458 |
| 510k Number | K770458 |
| Device Name: | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | ICN PHARMACEUTICALS, INC. 13 MOUNTAINVIEW AVE. ORANGEBURG, NY 10962 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-08 |
| Decision Date | 1977-05-10 |