The following data is part of a premarket notification filed by Carroll Biological Corp. with the FDA for Tryptic Soy Agar.
Device ID | K832611 |
510k Number | K832611 |
Device Name: | TRYPTIC SOY AGAR |
Classification | Culture Media, Non-selective And Non-differential |
Applicant | CARROLL BIOLOGICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-08 |
Decision Date | 1983-09-12 |