The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Aldosterone Assay.
Device ID | K050784 |
510k Number | K050784 |
Device Name: | NICHOLS ADVANTAGE ALDOSTERONE ASSAY |
Classification | Radioimmunoassay, Aldosterone |
Applicant | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
Contact | Xie Qiyi |
Product Code | CJM |
CFR Regulation Number | 862.1045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-03-28 |
Decision Date | 2005-06-01 |
Summary: | summary |