The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Direct Bilirubin.
| Device ID | K993771 |
| 510k Number | K993771 |
| Device Name: | CARESIDE DIRECT BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch CARESIDE, INC. 6100 BRISTOL PKWY. Culver City, CA 90230 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-08 |
| Decision Date | 1999-12-27 |
| Summary: | summary |