The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Total Bilirubin.
| Device ID | K003829 |
| 510k Number | K003829 |
| Device Name: | TOTAL BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274022528 | K003829 | 000 |
| 00817274021989 | K003829 | 000 |
| 00817274021972 | K003829 | 000 |
| 00817274021965 | K003829 | 000 |
| 00817274021958 | K003829 | 000 |
| 00817274021941 | K003829 | 000 |