510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182513Substantially Equivalent

FluChip-8G Influenza A+B Assay

Indevr, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182513 is the FDA 510(k) clearance record for FluChip-8G Influenza A+B Assay, a class II device, cleared for Indevr, Inc. on under FDA product code OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay). FDA's definition for product code OZE reads: "An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human...". FDA records list one 510(k) clearance for Indevr, Inc. As of , FDA records show no recalls naming K182513.

Clearance record

Decision date
Received
(222 days to decision)
Product code
OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Indevr, Inc. 2100 Central Ave., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZE

Trailing 12 months

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

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