The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Psi Total Protein Reagent.
| Device ID | K822468 |
| 510k Number | K822468 |
| Device Name: | PSI TOTAL PROTEIN REAGENT |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-17 |
| Decision Date | 1982-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015112 | K822468 | 000 |
| 00811727016270 | K822468 | 000 |
| 00817439021281 | K822468 | 000 |
| 00817439021304 | K822468 | 000 |
| 00811727011985 | K822468 | 000 |
| 00811727011992 | K822468 | 000 |
| 00811727012005 | K822468 | 000 |
| 00811727012012 | K822468 | 000 |
| 00811727012777 | K822468 | 000 |
| 00811727013101 | K822468 | 000 |
| 00811727013651 | K822468 | 000 |
| 00811727014382 | K822468 | 000 |
| 00811727014399 | K822468 | 000 |
| 00811727014405 | K822468 | 000 |
| 00811727014832 | K822468 | 000 |
| 00811727015976 | K822468 | 000 |