The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for Polystyrene Microtiter Well Immunosor.
| Device ID | K832345 |
| 510k Number | K832345 |
| Device Name: | POLYSTYRENE MICROTITER WELL IMMUNOSOR |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTIC REAGENT TECH. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-11-25 |