The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Total Bilirubin Reagent.
| Device ID | K955940 |
| 510k Number | K955940 |
| Device Name: | TOTAL BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Contact | Charles C Allain |
| Correspondent | Charles C Allain DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-21 |
| Decision Date | 1996-03-13 |