The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Aldosterone Assay.
| Device ID | K032188 |
| 510k Number | K032188 |
| Device Name: | NICHOLS ADVANTAGE ALDOSTERONE ASSAY |
| Classification | Radioimmunoassay, Aldosterone |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Contact | Jimmy Wong |
| Product Code | CJM |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-17 |
| Decision Date | 2003-07-31 |
| Summary: | summary |