FDA Product Code
FDA Product Code CJM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1045
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-04-21 | Traditional | PDF ↗ |
| K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | Diasorin | 2013-04-09 | Traditional | PDF ↗ |
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Nichols Institute Diagnostics | 2005-06-01 | Traditional | PDF ↗ |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Nichols Institute Diagnostics | 2003-07-31 | Traditional | PDF ↗ |
| K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1995-02-13 | Traditional | PDF ↗ |
| K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1992-07-10 | Traditional | PDF ↗ |
| K862204 | RSL (125I) ALDOSTERONE KIT | Radioassay Systems Laboratories, Inc. | 1986-09-25 | Traditional | PDF ↗ |
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | 1984-03-02 | Traditional | PDF ↗ |
| K831178 | COAT-A-COUNT NO-EXTRACTION ALDOSTERONE | Diagnostic Products Corp. | 1983-05-27 | Traditional | PDF ↗ |
| K800775 | ALDOCTK-125 | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 | Traditional | PDF ↗ |
| K781504 | 125I-ALDOSTERONE RIA DIAG. KIT | Abbott Laboratories | 1978-11-22 | Traditional | PDF ↗ |
| K771526 | 125 I ALDOSTERONE RIA KIT | Diagnostic Products Corp. | 1977-08-25 | Traditional | PDF ↗ |
Product code CJM · Class II · Clinical Chemistry. Data: openFDA.