The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Middlebrook & Cohn 7h10 Agar Base.
Device ID | K834205 |
510k Number | K834205 |
Device Name: | MIDDLEBROOK & COHN 7H10 AGAR BASE |
Classification | Culture Media, Non-selective And Differential |
Applicant | ACUMEDIA MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSH |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-05 |
Decision Date | 1984-01-03 |