The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl 1400.
Device ID | K822314 |
510k Number | K822314 |
Device Name: | DSL 1400 |
Classification | Radioimmunoassay, Estriol |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGI |
CFR Regulation Number | 862.1265 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-03 |
Decision Date | 1982-09-30 |