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

510(k) K111999

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

Recall on shared 510(k) K111999; other models may be affected

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK111999	Date17 Apr 2012Cleared	StatusActive

1 recall · 1 ongoing · FDA

- Ongoing Z-3303-2024 FDA Class II initiated 22 Aug 2024 on shared 510(k) K111999
The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)