The following data is part of a premarket notification filed by Hardy Media with the FDA for Sabouraud Dextrose Agar W/chloro.
Device ID | K880128 |
510k Number | K880128 |
Device Name: | SABOURAUD DEXTROSE AGAR W/CHLORO |
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 | 1988-01-06 |
Decision Date | 1988-03-30 |