510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190204Substantially Equivalent

ID NOW Influenza A & B 2

Alere Scarborough, Inc., Scarborough ME / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190204 is the FDA 510(k) clearance record for ID NOW Influenza A & B 2, a class II device, cleared for Alere Scarborough, 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 17 510(k) clearances for Alere Scarborough, Inc., from to . As of , FDA records show no recalls naming K190204.

Clearance record

Decision date
Received
(42 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
Alere Scarborough, Inc. 10 Southgate Rd., Scarborough ME
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