The following data is part of a premarket notification filed by Anarobe Systems with the FDA for Trypticase Soy Broth.
Device ID | K842849 |
510k Number | K842849 |
Device Name: | TRYPTICASE SOY BROTH |
Classification | Culture Media, General Nutrient Broth |
Applicant | ANAROBE SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSC |
CFR Regulation Number | 866.2350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-20 |
Decision Date | 1984-08-03 |