The following data is part of a premarket notification filed by Remel Co. with the FDA for Buffered Cye Agar Deep W/supplements.
Device ID | K840890 |
510k Number | K840890 |
Device Name: | BUFFERED CYE AGAR DEEP W/SUPPLEMENTS |
Classification | Culture Media, Selective And Non-differential |
Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-27 |
Decision Date | 1984-03-23 |