The following data is part of a premarket notification filed by Worthington Diagnostic Systems with the FDA for Compur Easy Touch Chemistry Analyzer-.
Device ID | K831227 |
510k Number | K831227 |
Device Name: | COMPUR EASY TOUCH CHEMISTRY ANALYZER- |
Classification | Analyzer, Chemistry, Micro, For Clinical Use |
Applicant | WORTHINGTON DIAGNOSTIC SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJF |
CFR Regulation Number | 862.2170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-15 |
Decision Date | 1983-06-02 |