The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Macconkey Agar, Plus.
Device ID | K842100 |
510k Number | K842100 |
Device Name: | MACCONKEY AGAR, PLUS |
Classification | Culture Media, Selective And Differential |
Applicant | ACUMEDIA MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-25 |
Decision Date | 1984-06-07 |