The following data is part of a premarket notification filed by Logos Scientific, Inc. with the FDA for Elvi 165 Proteo Seroskop.
Device ID | K842056 |
510k Number | K842056 |
Device Name: | ELVI 165 PROTEO SEROSKOP |
Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
Applicant | LOGOS SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQT |
CFR Regulation Number | 862.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-22 |
Decision Date | 1984-06-22 |