IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
FDA 510(k) clearance K142994 · decided 2015-04-21
Clearance details
- K-number
- K142994
- Device name
- IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
- Applicant
- Immunodiagnostic Systems , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-10-16
- Decision date
- 2015-04-21
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- CJM
- Device class
- 2
- Regulation number
- 862.1045
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Boldon, Tyne & Wear, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321) | Diasorin | 2013-04-09 |
| NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K050784) | Nichols Institute Diagnostics | 2005-06-01 |
| NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K032188) | Nichols Institute Diagnostics | 2003-07-31 |
| DSL ACTIVE ALDOSTERONE RIA (DSL 8600) (K943397) | Diagnostic Systems Laboratories, Inc. | 1995-02-13 |
| DSL ACTIVE ALDOSTERONE (DSL 8600) (K921205) | Diagnostic Systems Laboratories, Inc. | 1992-07-10 |
| RSL (125I) ALDOSTERONE KIT (K862204) | Radioassay Systems Laboratories, Inc. | 1986-09-25 |
| ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (K834428) | Serono Laboratories, Inc. | 1984-03-02 |
| COAT-A-COUNT NO-EXTRACTION ALDOSTERONE (K831178) | Diagnostic Products Corp. | 1983-05-27 |
| ALDOCTK-125 (K800775) | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 |
| 125I-ALDOSTERONE RIA DIAG. KIT (K781504) | Abbott Laboratories | 1978-11-22 |
| 125 I ALDOSTERONE RIA KIT (K771526) | Diagnostic Products Corp. | 1977-08-25 |
Recalls involving this device
No recalls on record reference this clearance.