CISBIO RENIN RIA TEST— 510(k) K062120
Substantially EquivalentCis Bio International
FDA 510(k) clearance K062120 for CISBIO RENIN RIA TEST, Substantially Equivalent on 2007-03-30. Applicant: Cis Bio International. Device class: 2.
Clearance details
- Applicant
- Cis Bio International
- Product code
- Code CIB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1085
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Stroudsburg, PA, US
Recent devices under product code CIB
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- K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- K061758 — ACTIVE RENIN IRMA
- K011128 — NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
- K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
Data sourced from openFDA. This site is unofficial and independent of the FDA.