The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Ims Hematology Mixer.
| Device ID | K823124 |
| 510k Number | K823124 |
| Device Name: | IMS HEMATOLOGY MIXER |
| Classification | Mixer, Blood Tube |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GLE |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-22 |
| Decision Date | 1982-11-22 |