INFINITI SYSTEM— 510(k) K060564
Substantially EquivalentAutoGenomics, Inc.
FDA 510(k) clearance K060564 for INFINITI SYSTEM, Substantially Equivalent on 2007-02-07. Applicant: AutoGenomics, Inc.. Device class: 2.
Clearance details
- Applicant
- AutoGenomics, Inc.
- Product code
- Code NPQ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7280
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code NPQ
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