The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Rsl's Assay Procedure Quantitation.
Device ID | K791728 |
510k Number | K791728 |
Device Name: | RSL'S ASSAY PROCEDURE QUANTITATION |
Classification | Radioimmunoassay, Estriol |
Applicant | RADIOASSAY 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 | 1979-08-30 |
Decision Date | 1979-09-27 |