IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
FDA 510(k) K142994 · Immunodiagnostic Systems , Ltd.
510(k) numberK142994
Submission
- Device name
- IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
- Applicant
- Immunodiagnostic Systems , Ltd.
Boldon, Tyne & Wear, GB - Received
- October 16, 2014
- Decision date
- April 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJM – Radioimmunoassay, Aldosterone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1045
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130321 | Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…CJM · Traditional | Diasorin | 04/09/2013SE |
| K050784 | Nichols Advantage Aldosterone AssayCJM · Traditional | Nichols Institute Diagnostics | 06/01/2005SE |
| K032188 | Nichols Advantage Aldosterone AssayCJM · Traditional | Nichols Institute Diagnostics | 07/31/2003SE |
| K943397 | DSL Active Aldosterone Ria (DSL 8600)CJM · Traditional | Diagnostic Systems Laboratories, Inc. | 02/13/1995SE |
| K921205 | DSL Active Aldosterone (DSL 8600)CJM · Traditional | Diagnostic Systems Laboratories, Inc. | 07/10/1992SE |
| K862204 | RSL (125I) Aldosterone KitCJM · Traditional | Radioassay Systems Laboratories, Inc. | 09/25/1986SE |
| K834428 | Aldosterone Radioimmunoassay Test KitCJM · Traditional | Serono Laboratories, Inc. | 03/02/1984SE |
| K831178 | Coat-A-Count No-Extraction AldosteroneCJM · Traditional | Diagnostic Products Corp. | 05/27/1983SE |
| K800775 | ALDOCTK-125CJM · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 04/21/1980SE |
| K781504 | 125I-ALDOSTERONE Ria Diag. KitCJM · Traditional | Abbott Laboratories | 11/22/1978SE |
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|---|---|---|
| K252728 | IDS-iSYS Total TestosteroneCDZ · Traditional | 04/15/2026SE |
| K240865 | IDS-iSYS Free TestosteroneCDZ · Traditional | 10/23/2024SE |
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| K202136 | IDS CortisolCGR · Traditional | 04/13/2021SE |
| K200475 | IDS-iSYS Ostase BAPCIN · Traditional | 09/30/2020SE |
| K190121 | Ids SHBGCDZ · Traditional | 06/17/2019SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | 01/31/2017SE |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG · Traditional | 11/15/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | 05/17/2016SE |
| K142351 | 25-Hydroxy Vitamin Ds EIAMRG · Traditional | 08/25/2015SE |
Questions and answers
When was IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers cleared by the FDA?
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (K142994) received a 510(k) decision of Substantially Equivalent on April 21, 2015, 187 days after the submission was received.
What is the product code of K142994?
The FDA product code is CJM – Radioimmunoassay, Aldosterone, a Class II (moderate risk) device regulated under 21 CFR 862.1045.