The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Autotechnicon V Tissue Process Sys.
Device ID | K834599 |
510k Number | K834599 |
Device Name: | AUTOTECHNICON V TISSUE PROCESS SYS |
Classification | Processor, Tissue, Automated |
Applicant | TECHNICON INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IEO |
CFR Regulation Number | 864.3875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-30 |
Decision Date | 1984-02-04 |