The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Flow-pac Alkaline Phosphate Reagent Set.
| Device ID | K830535 |
| 510k Number | K830535 |
| Device Name: | FLOW-PAC ALKALINE PHOSPHATE REAGENT SET |
| Classification | Tetrabromophenolphthalein, Albumin |
| Applicant | AMRESCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CJF |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-18 |
| Decision Date | 1983-03-24 |