510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K153597Substantially Equivalent

Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

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

K153597 is the FDA 510(k) clearance record for Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card, a class II device, cleared for Healgen Scientific,, LLC on under FDA product code JXM (Enzyme Immunoassay, Benzodiazepine). FDA records list 27 510(k) clearances for Healgen Scientific,, LLC, from to . As of , FDA records show no recalls naming K153597.

Clearance record

Decision date
Received
(159 days to decision)
Product code
JXM Enzyme Immunoassay, Benzodiazepine
Regulation
21 CFR 862.3170
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Healgen Scientific,, LLC 5213 Maple St., Bellaire TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXM

Trailing 12 months

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

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