The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Dual Vial Creatinine Reagent.
| Device ID | K983937 |
| 510k Number | K983937 |
| Device Name: | DUAL VIAL CREATININE REAGENT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| 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 | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-05 |
| Decision Date | 1999-01-06 |