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 |