The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Psi Albumin Reagent.
| Device ID | K822471 |
| 510k Number | K822471 |
| Device Name: | PSI ALBUMIN REAGENT |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| 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 |
|---|---|---|
| 00811727014894 | K822471 | 000 |
| 00811727010018 | K822471 | 000 |
| 00817439020116 | K822471 | 000 |
| 00817439020109 | K822471 | 000 |
| 00817439020093 | K822471 | 000 |
| 00817274022696 | K822471 | 000 |
| 00817274020678 | K822471 | 000 |
| 00817274020661 | K822471 | 000 |
| 00811727016003 | K822471 | 000 |
| 00811727010025 | K822471 | 000 |
| 00811727010032 | K822471 | 000 |
| 00811727010049 | K822471 | 000 |
| 00811727014634 | K822471 | 000 |
| 00811727014627 | K822471 | 000 |
| 00811727013705 | K822471 | 000 |
| 00811727013699 | K822471 | 000 |
| 00811727013682 | K822471 | 000 |
| 00811727013385 | K822471 | 000 |
| 00811727012869 | K822471 | 000 |
| 00811727012524 | K822471 | 000 |
| 00811727015693 | K822471 | 000 |