The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Lombard-dowell Starch Agar.
Device ID | K790618 |
510k Number | K790618 |
Device Name: | LOMBARD-DOWELL STARCH AGAR |
Classification | Culture Media, Non-selective And Differential |
Applicant | ANAEROBE SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSH |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-29 |
Decision Date | 1979-04-23 |