The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Total Estriol Ria Kit.
Device ID | K800036 |
510k Number | K800036 |
Device Name: | TOTAL ESTRIOL RIA KIT |
Classification | Radioimmunoassay, Estriol |
Applicant | AMERSHAM CORP. 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 | 1980-01-07 |
Decision Date | 1980-01-21 |