The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for S-mem-joklik's Powder.
Device ID | K821911 |
510k Number | K821911 |
Device Name: | S-MEM-JOKLIK'S POWDER |
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 | 1982-06-28 |
Decision Date | 1982-07-27 |