The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Direct Bilirubin Reagent.
| Device ID | K011972 |
| 510k Number | K011972 |
| Device Name: | DIRECT BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview, WA 98632 |
| Contact | Mark E Legaz |
| Correspondent | Mark E Legaz 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 | 2001-06-25 |
| Decision Date | 2001-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851445007204 | K011972 | 000 |
| 00851445007198 | K011972 | 000 |