510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912371Substantially Equivalent

Biomerieux Rsv Direct If Kit

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

K912371 is the FDA 510(k) clearance record for BIOMERIEUX RSV DIRECT IF KIT, a class I device, cleared for Vitek Systems, Inc. on under FDA product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa). FDA records list 39 510(k) clearances for Vitek Systems, Inc., from to . As of , FDA records show no recalls naming K912371.

Clearance record

Decision date
Received
(117 days to decision)
Product code
LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Vitek Systems, Inc. 595 Anglum Dr., Hazelwood MI
510(k) summary
Statement
Third party review
No

Clearances, product code LKT

Trailing 12 months

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

FDA records show no clearances under product code LKT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKT, 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