The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Vitalab Direct Bilirubin Reagent.
| Device ID | K040631 |
| 510k Number | K040631 |
| Device Name: | VITALAB DIRECT BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | CLINICAL DATA, INC. 1075 WEST LAMBERT ROAD Brea, CA 92821 -2944 |
| Contact | Wynn Stocking |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-03-10 |
| Decision Date | 2004-03-18 |
| Summary: | summary |