INFINITI SYSTEM
FDA 510(k) clearance K060564 · decided 2007-02-07
Clearance details
- K-number
- K060564
- Device name
- INFINITI SYSTEM
- Applicant
- AutoGenomics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-03
- Decision date
- 2007-02-07
- Days to decision
- 341 days
- Clearance type
- Traditional
- Product code
- NPQ
- Device class
- 2
- Regulation number
- 864.7280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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| INVADER FACTOR V (K100980) | Hologic, Inc. | 2011-06-01 |
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| FACTOR V LEIDEN KIT (DEN030005) | Roche Diagnostics Corp. | 2003-12-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AvertD and AvertD Buccal Sample Collection Kit (P230032/S002) | AutoGenomics, Inc. | 2024-11-07 |
| AvertD and AvertD Buccal Sample Collection Kit (P230032/S001) | AutoGenomics, Inc. | 2024-02-16 |
| AvertD and AvertD Buccal Sample Collection Kit (P230032) | AutoGenomics, Inc. | 2023-12-19 |