AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
FDA 510(k) clearance DEN040012 · decided 2004-12-23
Clearance details
- K-number
- DEN040012
- Device name
- AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
- Applicant
- Affymetrix, Inc.
- Decision
- Unknown
- Date received
- 2004-11-03
- Decision date
- 2004-12-23
- Days to decision
- 50 days
- Clearance type
- Post-NSE
- Product code
- NSU
- Device class
- 2
- Regulation number
- 862.2570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.