CISBIO RENIN RIA TEST
FDA 510(k) clearance K062120 · decided 2007-03-30
Clearance details
- K-number
- K062120
- Device name
- CISBIO RENIN RIA TEST
- Applicant
- Cis Bio International
- Decision
- Substantially Equivalent
- Date received
- 2006-07-25
- Decision date
- 2007-03-30
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- CIB
- Device class
- 2
- Regulation number
- 862.1085
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Stroudsburg, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.