510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K861379Substantially Equivalent

Monabrite Respir Syncytial Virus(rsv) Test Kit

Serono Diagnostics, Inc., Norwell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861379 is the FDA 510(k) clearance record for MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT, a class I device, cleared for Serono Diagnostics, Inc. on under FDA product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa). FDA records list 25 510(k) clearances for Serono Diagnostics, Inc., from to . As of , FDA records show no recalls naming K861379.

Clearance record

Decision date
Received
(93 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
Serono Diagnostics, Inc. 100 Longwater Cir., Norwell MA
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