The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Ouchterlony Agar Plates.
Device ID | K792699 |
510k Number | K792699 |
Device Name: | OUCHTERLONY AGAR PLATES |
Classification | Plates And Equipment, Radial Immunodiffusion |
Applicant | MERIDIAN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JZQ |
CFR Regulation Number | 866.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-27 |
Decision Date | 1980-01-24 |