The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Midas Ii Automatic Stainer.
Device ID | K842077 |
510k Number | K842077 |
Device Name: | MIDAS II AUTOMATIC STAINER |
Classification | Slide Stainer, Automated |
Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPA |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-23 |
Decision Date | 1984-07-27 |