510(k) K103112
- Device
- AFFYMETRIX GENE PROFILING REAGENTS
- Applicant
- Affymetrix, Inc.
- 510(k) number
- K103112
- Product code
- OVA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-04
- Date received
- 2010-10-21
- Regulation
- 862.2570
- Classification name
- Complete Gene Expression Profiling Accessory Reagents
- Medical specialty
- Clinical Chemistry
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAUREEN MENDE
- Address
- 3 Lagoon Dr. Suite 160 Redwood Shores CA US 94065 94065
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary