FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
K Number: K123763
·
Decision Dec 24, 2013
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
23
Review Days
382
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Basic Information
- Device Name
- IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
- K Number
- K123763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1085
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Immunodiagnostic Systems , Ltd.
- Date Received
- December 7, 2012
- Decision Date
- December 24, 2013
- Product Code
- CIB
- 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 |
|---|---|---|---|
| CIB | Radioimmunoassay, Angiotensin I And Renin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIB), ordered by most recent decision date.
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
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NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
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ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BUHLMANN ANGIOSTENSIN II RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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