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 |