The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Brilliant Green Agar W/sulfadiazine.
Device ID | K881530 |
510k Number | K881530 |
Device Name: | BRILLIANT GREEN AGAR W/SULFADIAZINE |
Classification | Culture Media, Selective And Non-differential |
Applicant | ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore, MD 21211 |
Contact | Cunningham, Phd |
Correspondent | Cunningham, Phd ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore, MD 21211 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-08 |
Decision Date | 1988-04-18 |