The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for 17b Estradiol.
Device ID | K810204 |
510k Number | K810204 |
Device Name: | 17B ESTRADIOL |
Classification | Radioimmunoassay, Estradiol |
Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHP |
CFR Regulation Number | 862.1260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-26 |
Decision Date | 1981-03-27 |