The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Seed Agar.
Device ID | K832577 |
510k Number | K832577 |
Device Name: | SEED AGAR |
Classification | Culture Media, Antibiotic Assay |
Applicant | ACUMEDIA MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSA |
CFR Regulation Number | 866.2350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-02 |
Decision Date | 1983-09-12 |