510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111999Substantially Equivalent

Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent Strip for Urinal

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

K111999 is the FDA 510(k) clearance record for HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL, a class II device, cleared for Healgen Scientific,, LLC on under FDA product code JIO (Blood, Occult, Colorimetric, In Urine). FDA records list 27 510(k) clearances for Healgen Scientific,, LLC, from to . As of , FDA records show one recall naming K111999.

Clearance record

Decision date
Received
(279 days to decision)
Product code
JIO Blood, Occult, Colorimetric, In Urine
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Healgen Scientific,, LLC 5213 Maple St., Bellaire TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIO

Trailing 12 months

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

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