The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Urine/csf Microprotein Reagent.
| Device ID | K913225 |
| 510k Number | K913225 |
| Device Name: | URINE/CSF MICROPROTEIN REAGENT |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | INTERSECT SYSTEMS, INC. 1152 3RD AVE., SUITE D/E P.O. BOX 2219 Longview, WA 98632 |
| Contact | Mark E Legaz |
| Correspondent | Mark E Legaz INTERSECT SYSTEMS, INC. 1152 3RD AVE., SUITE D/E P.O. BOX 2219 Longview, WA 98632 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-19 |
| Decision Date | 1991-10-11 |