510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896097Substantially Equivalent

Vidas Respiratory Syncytial Virus (Rsv) Assay

Vitek Systems, Inc., Hazelwood MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896097 is the FDA 510(k) clearance record for VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY, a class I device, cleared for Vitek Systems, Inc. on under FDA product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus). FDA records list 39 510(k) clearances for Vitek Systems, Inc., from to . As of , FDA records show no recalls naming K896097.

Clearance record

Decision date
Received
(129 days to decision)
Product code
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Vitek Systems, Inc. 595 Anglum Dr., Hazelwood MI
Third party review
No

Clearances, product code GQG

Trailing 12 months
1 clearance under product code GQG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260