AVC A/H5N1 FLU TEST
FDA 510(k) clearance K083278 · decided 2009-04-08
Clearance details
- K-number
- K083278
- Device name
- AVC A/H5N1 FLU TEST
- Applicant
- Arbor Vita Corportation
- Decision
- Substantially Equivalent
- Date received
- 2008-11-07
- Decision date
- 2009-04-08
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- OMS
- Device class
- 2
- Regulation number
- 866.3332
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.