AFFYMETRIX GENE PROFILING REAGENTS
FDA 510(k) clearance K103112 · decided 2011-05-04
Clearance details
- K-number
- K103112
- Device name
- AFFYMETRIX GENE PROFILING REAGENTS
- Applicant
- Affymetrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-21
- Decision date
- 2011-05-04
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- OVA
- Device class
- 2
- Regulation number
- 862.2570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Redwood Shores, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.