HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL— 510(k) K111999

Clearance details

Applicant

Healgen Scientific,, LLC

Product code

Code JIO

Device class

Class 2

Regulation

21 CFR 864.6550

Advisory panel

Hematology

Date received

2011-07-13

Decision date

2012-04-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bellaire, TX, US

• K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips2024-04-26
• K111221 — MISSION U500 URINE ANALYZER2012-01-18
• K082811 — URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS2009-09-11
• K083724 — WIENER LAB. URINE STRIP 10 AND 112009-09-02
• K040703 — URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS2004-08-26

• K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test2026-04-13
• K253705 — Healgen® Accurate Oral Fluid Drug Test2026-03-16
• K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC2026-02-12
• K251800 — Healgen® URS Test Strips2025-12-23
• K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card2025-12-23

• Z-3303-2024 — Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.Class II·Ongoing·Healgen Scientific Llc·20240822

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111999.