510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884191Substantially Equivalent

Influenza a Ifa Test for Direct Antigen Detection

Baxter Diagnostics, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884191 is the FDA 510(k) clearance record for INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION, a class I device, cleared for Baxter Diagnostics, Inc. on under FDA product code GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K884191.

Clearance record

Decision date
Received
(47 days to decision)
Product code
GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Regulation
21 CFR 866.3330
Device class
Class I
Review panel
Microbiology
Applicant
Baxter Diagnostics, Inc. P.O.Box 520672, Miami FL
Third party review
No

Clearances, product code GNX

Trailing 12 months

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

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