510(k) K083278
- Device
- AVC A/H5N1 FLU TEST
- Applicant
- ARBOR VITA CORPORTATION
- 510(k) number
- K083278
- Product code
- OMS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-08
- Date received
- 2008-11-07
- Regulation
- 866.3332
- Classification name
- Novel Influenza A Virus, A/h5 Ns1 Protein
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA ALLISTER
- Address
- 772 Lucerne Dr. Sunnyvale CA US 94085 94085
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary