510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093815Substantially Equivalent

Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124

EMD Millipore Corporation, Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093815 is the FDA 510(k) clearance record for LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124, a class II device, cleared for Millipore Corporation on under FDA product code OMG (Antisera, Fluorescent, Human Metapneumovirus). FDA's definition for product code OMG reads: "It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with...". FDA records list 94 510(k) clearances for EMD MILLIPORE CORPORATION, from to . As of , FDA records show no recalls naming K093815.

Clearance record

Decision date
Received
(88 days to decision)
Product code
OMG Antisera, Fluorescent, Human Metapneumovirus
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Millipore Corporation 28820 Single Oak Dr., Temecula CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMG

Trailing 12 months

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

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