FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
K Number: K121944
·
Decision Jan 1, 2013
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
71
Review Days
182
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Basic Information
- Device Name
- LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- K Number
- K121944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1085
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- July 3, 2012
- Decision Date
- January 1, 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.
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
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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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