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
K181473Substantially Equivalent

DENV Detect NS1 ELISA

Inbios International, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K181473 is the FDA 510(k) clearance record for DENV Detect NS1 ELISA, a class II device, cleared for InBios International, Inc. on under FDA product code QCU (Dengue Virus Antigen Assay). FDA's definition for product code QCU reads: "Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection". FDA records list 7 510(k) clearances for InBios International, Inc., from to . As of , FDA records show no recalls naming K181473.

Clearance record

Decision date
Received
(84 days to decision)
Product code
QCU Dengue Virus Antigen Assay
Regulation
21 CFR 866.3945
Device class
Class II
Review panel
Microbiology
Applicant
InBios International, Inc. 307 Westlake Ave. N, Suite 300, Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code QCU

Trailing 12 months

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

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