The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Estriol Radioimmunoassay Kit.
Device ID | K840301 |
510k Number | K840301 |
Device Name: | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT |
Classification | Radioimmunoassay, Estriol |
Applicant | NEW ENGLAND NUCLEAR 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 | 1984-01-24 |
Decision Date | 1984-03-30 |