510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083278Substantially Equivalent

Avc A/h5n1 Flu Test

Arbor Vita Corportation, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083278 is the FDA 510(k) clearance record for AVC A/H5N1 FLU TEST, a class II device, cleared for Arbor Vita Corportation on under FDA product code OMS (Novel Influenza A Virus, A/H5 Ns1 Protein). FDA's definition for product code OMS reads: "Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1...". FDA records list one 510(k) clearance for Arbor Vita Corportation. As of , FDA records show no recalls naming K083278.

Clearance record

Decision date
Received
(152 days to decision)
Product code
OMS Novel Influenza A Virus, A/H5 Ns1 Protein
Regulation
21 CFR 866.3332
Device class
Class II
Review panel
Microbiology
Applicant
Arbor Vita Corportation 772 Lucerne Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMS

Trailing 12 months

FDA records hold no clearances under product code OMS in the trailing twelve months.

FDA records show no clearances under product code OMS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260