The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Total Estrogens Kit By Ria.
Device ID | K791651 |
510k Number | K791651 |
Device Name: | TOTAL ESTROGENS KIT BY RIA |
Classification | Radioimmunoassay, Total Estrogens, Nonpregnancy |
Applicant | RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JMD |
CFR Regulation Number | 862.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-21 |
Decision Date | 1979-09-27 |