The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for Polystyrene Microtiter Plate Immunosorb.
| Device ID | K830653 |
| 510k Number | K830653 |
| Device Name: | POLYSTYRENE MICROTITER PLATE IMMUNOSORB |
| Classification | Ige, Peroxidase, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTIC REAGENT TECH. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGO |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-01 |
| Decision Date | 1983-04-08 |