The following data is part of a premarket notification filed by Hardy Media with the FDA for Chocolate Agar W/bacitracin, Chocolate W/bacitraci.
Device ID | K850555 |
510k Number | K850555 |
Device Name: | CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI |
Classification | Culture Media, Selective And Non-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 | JSJ |
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 | 1985-04-01 |