The following data is part of a premarket notification filed by Arbor Vita Corportation with the FDA for Avc A/h5n1 Flu Test.
| Device ID | K083278 |
| 510k Number | K083278 |
| Device Name: | AVC A/H5N1 FLU TEST |
| Classification | Novel Influenza A Virus, A/h5 Ns1 Protein |
| Applicant | ARBOR VITA CORPORTATION 772 LUCERNE DRIVE Sunnyvale, CA 94085 |
| Contact | Linda Allister |
| Correspondent | Linda Allister ARBOR VITA CORPORTATION 772 LUCERNE DRIVE Sunnyvale, CA 94085 |
| Product Code | OMS |
| CFR Regulation Number | 866.3332 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-07 |
| Decision Date | 2009-04-08 |
| Summary: | summary |