The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Microprotein-pr.
| Device ID | K915380 |
| 510k Number | K915380 |
| Device Name: | MICROPROTEIN-PR |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William Gilbert |
| Correspondent | William Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-02-18 |