510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123703Substantially Equivalent

Healgen Hcg One Step Pregnancy Test (Strip), Healgen Hcg One Step Pregnancy Test (Cassette)

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

K123703 is the FDA 510(k) clearance record for HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE), a class II device, cleared for Healgen Scientific,, LLC on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 27 510(k) clearances for Healgen Scientific,, LLC, from to . As of , FDA records show 3 recalls naming K123703.

Clearance record

Decision date
Received
(128 days to decision)
Product code
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Healgen Scientific,, LLC 3818 Fuqua St., Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code LCX

Trailing 12 months

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

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