FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
K Number: K142994
·
Decision Apr 21, 2015
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
11
Applicant Total
23
Review Days
187
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Basic Information
- Device Name
- IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
- K Number
- K142994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1045
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunodiagnostic Systems , Ltd.
- Date Received
- October 16, 2014
- Decision Date
- April 21, 2015
- Product Code
- CJM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CJM | Radioimmunoassay, Aldosterone | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CJM), ordered by most recent decision date.
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
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DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
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FDA 510(k)
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RSL (125I) ALDOSTERONE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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