The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Midas 6000 Automatic Stainer.
Device ID | K832994 |
510k Number | K832994 |
Device Name: | MIDAS 6000 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 | 1983-09-02 |
Decision Date | 1983-09-29 |