ALDOCTK-125
FDA 510(k) K800775 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK800775
Submission
- Device name
- ALDOCTK-125
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
Mchenry, IL, US - Received
- April 7, 1980
- Decision date
- April 21, 1980
- 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 |
| K781504 | 125I-ALDOSTERONE Ria Diag. KitCJM · Traditional | Abbott Laboratories | 11/22/1978SE |
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Questions and answers
When was ALDOCTK-125 cleared by the FDA?
ALDOCTK-125 (K800775) received a 510(k) decision of Substantially Equivalent on April 21, 1980, 14 days after the submission was received.
What is the product code of K800775?
The FDA product code is CJM – Radioimmunoassay, Aldosterone, a Class II (moderate risk) device regulated under 21 CFR 862.1045.