The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for Polystyrene Micro-liter Plate-birchtree.
Device ID | K831984 |
510k Number | K831984 |
Device Name: | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE |
Classification | Ige, Peroxidase, Antigen, Antiserum, Control |
Applicant | DIAGNOSTIC REAGENT TECH. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DGO |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-20 |
Decision Date | 1983-11-21 |