The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Midas 1000 Wright Giemsa Stain #66020.
Device ID | K822981 |
510k Number | K822981 |
Device Name: | MIDAS 1000 WRIGHT GIEMSA STAIN #66020 |
Classification | Wright's Stain |
Applicant | EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IAF |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-08 |
Decision Date | 1982-10-27 |