The following data is part of a premarket notification filed by Dms Laboratories with the FDA for Fast Violet B.
Device ID | K821038 |
510k Number | K821038 |
Device Name: | FAST VIOLET B |
Classification | Stains, Microbiologic |
Applicant | DMS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTS |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-13 |
Decision Date | 1982-05-27 |