510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232377Substantially Equivalent

Healgen Rapid COVID-19 Antigen Test

Healgen Scientific LLC, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232377 is the FDA 510(k) clearance record for Healgen Rapid COVID-19 Antigen Test, a class II device, cleared for Healgen Scientific,, LLC on under FDA product code QVF (Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings). FDA's definition for product code QVF reads: "A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an...". FDA records list 27 510(k) clearances for Healgen Scientific,, LLC, from to . As of , FDA records show no recalls naming K232377.

Clearance record

Decision date
Received
(255 days to decision)
Product code
QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Regulation
21 CFR 866.3982
Device class
Class II
Review panel
Microbiology
Applicant
Healgen Scientific,, LLC 3818 Fuqua St., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVF

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