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
K063261Substantially Equivalent

Nuclisens Easyq Enterovirus System

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063261 is the FDA 510(k) clearance record for NUCLISENS EASYQ ENTEROVIRUS SYSTEM, a class II device, cleared for bioMerieux, Inc. on under FDA product code OAI (Assay, Enterovirus Nucleic Acid). FDA's definition for product code OAI reads: "Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The...". FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K063261.

Clearance record

Decision date
Received
(602 days to decision)
Product code
OAI Assay, Enterovirus Nucleic Acid
Regulation
21 CFR 866.3225
Device class
Class II
Review panel
Microbiology
Applicant
bioMerieux, Inc. 100 Rodolphe St., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAI

Trailing 12 months

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

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