125 I Aldosterone Ria Kit
FDA 510(k) K771526 · Diagnostic Products Corp.
510(k) numberK771526
Submission
- Device name
- 125 I Aldosterone Ria Kit
- Applicant
- Diagnostic Products Corp.
Mchenry, IL, US - Received
- August 8, 1977
- Decision date
- August 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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Questions and answers
When was 125 I Aldosterone Ria Kit cleared by the FDA?
125 I Aldosterone Ria Kit (K771526) received a 510(k) decision of Substantially Equivalent on August 25, 1977, 17 days after the submission was received.
What is the product code of K771526?
The FDA product code is CJM – Radioimmunoassay, Aldosterone, a Class II (moderate risk) device regulated under 21 CFR 862.1045.