Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers
FDA 510(k) K130321 · Diasorin
510(k) numberK130321
Submission
- Device name
- Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers
- Applicant
- Diasorin
Stillwater, MN, US - Received
- February 8, 2013
- Decision date
- April 9, 2013
- 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 |
|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…CJM · Traditional | Immunodiagnostic Systems , Ltd. | 04/21/2015SE |
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXLOM · Traditional | 06/04/2026SE |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY · Traditional | 10/27/2023SE |
| K223403 | LIAISON Anti-HAV; LIAISON XSLOL · Special | 12/09/2022SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | 07/26/2022SE |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS · Traditional | 07/14/2022SE |
| K193650 | LIAISON FerritinDBF · Traditional | 09/14/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K210272 | LIAISON Anti-HAVLOL · Special | 02/09/2021SE |
| K201908 | LIAISON Testosterone xtCDZ · Special | 10/15/2020SE |
Questions and answers
When was Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers cleared by the FDA?
Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers (K130321) received a 510(k) decision of Substantially Equivalent on April 9, 2013, 60 days after the submission was received.
What is the product code of K130321?
The FDA product code is CJM – Radioimmunoassay, Aldosterone, a Class II (moderate risk) device regulated under 21 CFR 862.1045.