The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Total Bilirubin Reagent.
| Device ID | K003892 |
| 510k Number | K003892 |
| Device Name: | TOTAL BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview, WA 98632 |
| Contact | Joan Cathey |
| Correspondent | Joan Cathey INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview, WA 98632 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-18 |
| Decision Date | 2001-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851445007280 | K003892 | 000 |
| 00851445007273 | K003892 | 000 |
| 00851445007266 | K003892 | 000 |