510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253971Substantially Equivalent

Visby Medical Flu and COVID-19 Test

Visby Medical, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253971 is the FDA 510(k) clearance record for Visby Medical Flu and COVID-19 Test, a class II device, cleared for Visby Medical, Inc. on under FDA product code SIA (Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test). FDA's definition for product code SIA reads: "An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be...". FDA records list 6 510(k) clearances for Visby Medical, Inc., from to . As of , FDA records show no recalls naming K253971.

Clearance record

Decision date
Received
(167 days to decision)
Product code
SIA Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
Regulation
21 CFR 866.3984
Device class
Class II
Review panel
Microbiology
Applicant
Visby Medical, Inc. 3010 N. First St., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SIA

Trailing 12 months
1 clearance under product code SIA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260