The following data is part of a premarket notification filed by Granite Diagnostics, Inc. with the FDA for Corn Meal Agar W/polysorbate 80.
Device ID | K822994 |
510k Number | K822994 |
Device Name: | CORN MEAL AGAR W/POLYSORBATE 80 |
Classification | Culture Media, Selective And Non-differential |
Applicant | GRANITE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-12 |
Decision Date | 1982-11-16 |