The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Acth Ria System-dsi 2300.
Device ID | K830893 |
510k Number | K830893 |
Device Name: | ACTH RIA SYSTEM-DSI 2300 |
Classification | Radioimmunoassay, Acth |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CKG |
CFR Regulation Number | 862.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-21 |
Decision Date | 1983-04-27 |