The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for Logipe A Data Reducsystem Ip Specific-.
Device ID | K831774 |
510k Number | K831774 |
Device Name: | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- |
Classification | Ige, Peroxidase, Antigen, Antiserum, Control |
Applicant | DIAGNOSTIC REAGENT TECH. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DGO |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-02 |
Decision Date | 1983-07-18 |