The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Lx-100 Slide Stainer.
| Device ID | K880745 |
| 510k Number | K880745 |
| Device Name: | LX-100 SLIDE STAINER |
| Classification | Slide Stainer, Automated |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974 |
| Contact | Joseph Catarious |
| Correspondent | Joseph Catarious INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974 |
| Product Code | KPA |
| CFR Regulation Number | 864.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-24 |
| Decision Date | 1988-04-27 |