The following data is part of a premarket notification filed by Hardy Media with the FDA for Bhi With Sheep Blood (5%).
Device ID | K870639 |
510k Number | K870639 |
Device Name: | BHI WITH SHEEP BLOOD (5%) |
Classification | Culture Media, Non-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 | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-13 |
Decision Date | 1987-04-14 |