The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Total Bilirubin L.f..
| Device ID | K895822 |
| 510k Number | K895822 |
| Device Name: | TOTAL BILIRUBIN L.F. |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | King, Ph.d. |
| Correspondent | King, Ph.d. SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-29 |
| Decision Date | 1989-11-14 |