The following data is part of a premarket notification filed by Logos Scientific, Inc. with the FDA for Eurochima Serum Protein Electrophoresis Method.
Device ID | K844710 |
510k Number | K844710 |
Device Name: | EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD |
Classification | Apparatus, Electrophoresis, For Clinical Use |
Applicant | LOGOS SCIENTIFIC, INC. 700 SUNSET RD. Henderson, NV 89015 |
Contact | Douglas R Ward |
Correspondent | Douglas R Ward LOGOS SCIENTIFIC, INC. 700 SUNSET RD. Henderson, NV 89015 |
Product Code | JJN |
CFR Regulation Number | 862.2485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-03 |
Decision Date | 1985-01-07 |