510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251753Substantially Equivalent

GenaCheck COVID-19 Rapid Self-Test

Genabio Diagnostics Inc, Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251753 is the FDA 510(k) clearance record for GenaCheck COVID-19 Rapid Self-Test, a class II device, cleared for Genabio Diagnostics, Inc. on under FDA product code QYT (Over-The-Counter Covid-19 Antigen Test). FDA's definition for product code QYT reads: "For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older". FDA records list 2 510(k) clearances for Genabio Diagnostics, Inc., from to . As of , FDA records show no recalls naming K251753.

Clearance record

Decision date
Received
(88 days to decision)
Product code
QYT Over-The-Counter Covid-19 Antigen Test
Regulation
21 CFR 866.3984
Device class
Class II
Review panel
Microbiology
Applicant
Genabio Diagnostics, Inc. 19 Crosby Dr. Suite 220, Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYT

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