The following data is part of a premarket notification filed by Logos Scientific, Inc. with the FDA for Elvi 70 Safety Chamber.
Device ID | K841804 |
510k Number | K841804 |
Device Name: | ELVI 70 SAFETY CHAMBER |
Classification | Apparatus, Electrophoresis, For Clinical Use |
Applicant | LOGOS SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJN |
CFR Regulation Number | 862.2485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-01 |
Decision Date | 1984-05-31 |