510(k) K050784
- Device
- NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- Applicant
- NICHOLS INSTITUTE DIAGNOSTICS
- 510(k) number
- K050784
- Product code
- CJM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-01
- Date received
- 2005-03-28
- Regulation
- 862.1045
- Classification name
- Radioimmunoassay, Aldosterone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Xie Qiyi
- Address
- 1311 Calle Batido San Clemente CA US 92673 92673
FDA Registration Numbers#
- 2020726
- 2182595
- 8021924
- 3022178699
- 3007118747
Source Documents#
Other 510(k) Records For Product Code CJM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-04-21 |
| K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | Diasorin | 2013-04-09 |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Nichols Institute Diagnostics | 2003-07-31 |
| K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1995-02-13 |
| K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1992-07-10 |
| K862204 | RSL (125I) ALDOSTERONE KIT | Radioassay Systems Laboratories, Inc. | 1986-09-25 |
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | 1984-03-02 |
| K831178 | COAT-A-COUNT NO-EXTRACTION ALDOSTERONE | Diagnostic Products Corp. | 1983-05-27 |
| K800775 | ALDOCTK-125 | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 |
| K781504 | 125I-ALDOSTERONE RIA DIAG. KIT | Abbott Laboratories | 1978-11-22 |
| K771526 | 125 I ALDOSTERONE RIA KIT | Diagnostic Products Corp. | 1977-08-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary