The following data is part of a premarket notification filed by Hardy Media with the FDA for Bile Esculin Agar W/azide, Bea W/azide.
Device ID | K850552 |
510k Number | K850552 |
Device Name: | BILE ESCULIN AGAR W/AZIDE, BEA W/AZIDE |
Classification | Culture Media, Selective And Differential |
Applicant | HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara, CA 93101 |
Contact | Jay Hardy |
Correspondent | Jay Hardy HARDY MEDIA 205 W.MONTECITO ST. Santa Barbara, CA 93101 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-11 |
Decision Date | 1985-03-11 |