The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Ferritin Irma.
Device ID | K841925 |
510k Number | K841925 |
Device Name: | DSL FERRITIN IRMA |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-10 |
Decision Date | 1984-05-25 |