The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for In-vitro Test Determination Total Bilirubin.
| Device ID | K854180 |
| 510k Number | K854180 |
| Device Name: | IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Contact | Israel M Stein |
| Correspondent | Israel M Stein CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1985-11-25 |