REAL-TIME PCR INTERNAL CONTROL 2B SET
FDA 510(k) clearance K083430 · decided 2009-01-15
Clearance details
- K-number
- K083430
- Device name
- REAL-TIME PCR INTERNAL CONTROL 2B SET
- Applicant
- Nanogen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-19
- Decision date
- 2009-01-15
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- OLD
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.