ISE INDIRECT NA, K, CL FOR GEN.2
FDA 510(k) clearance K053165 · decided 2005-12-14
Clearance details
- K-number
- K053165
- Device name
- ISE INDIRECT NA, K, CL FOR GEN.2
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-14
- Decision date
- 2005-12-14
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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