The following data is part of a premarket notification filed by Isle Media And Sterile Products, Inc. with the FDA for Azide Blood Agar Base W/&wthot Shp. Bld.
Device ID | K800158 |
510k Number | K800158 |
Device Name: | AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD |
Classification | Culture Media, Selective And Non-differential |
Applicant | ISLE MEDIA AND STERILE PRODUCTS, 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 | 1980-01-24 |
Decision Date | 1980-02-13 |