The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Fungizone.
Device ID | K810784 |
510k Number | K810784 |
Device Name: | FUNGIZONE |
Classification | Media And Components, Synthetic Cell And Tissue Culture |
Applicant | DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIT |
CFR Regulation Number | 864.2220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-23 |
Decision Date | 1981-03-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FUNGIZONE 88356519 not registered Live/Pending |
Woodward Pharma Services LLC 2019-03-26 |
FUNGIZONE 78037404 2591640 Dead/Cancelled |
E.R. Squibb & Sons, L.L.C. 2000-12-01 |
FUNGIZONE 72000820 0637622 Dead/Expired |
OLIN MATHIESON CHEMICAL CORPORATION 1956-01-16 |