510(k) Report

510(k) · Cleared

Cleared

Uric Acid Reagent Set

K860111510(k) TraditionalCleared Feb 19, 198637-day reviewClass I21 CFR 862.1775

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Technostics Intl. · LFQ Acid, Uric, Acid Reduction Of Ferric Ion

Cleared on Feb 19, 1986 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 19, 1986
Review
37 days
Class
Class I
Product code
LFQ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K860111Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LFQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LFQ devices

LFQ Acid, Uric, Acid Reduction Of Ferric Ion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFQ

FDA has decided no LFQ device since 2007.

Median 510(k) review, days · LFQ

Too few LFQ 510(k)s in any year since 2007 to give a median.

Recalls per year · LFQ

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFQ

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code LFQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—10
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

More from Technostics Intl.

21 FDA decisions under this applicant name. See the company

  • K855188CPK (UV) Reagent KitTechnostics Intl. · 1986
  • K855190Magnesium Reagent SetTechnostics Intl. · 1986
  • K860110Glutamic Pyruvic Transaminase, GPT (UV) Reagent SetTechnostics Intl. · 1986
  • K860109Enzymatic Urea Nitrogen Reagent SetTechnostics Intl. · 1986
  • K860112Total Lipids Reagent SetTechnostics Intl. · 1986

Recent decisions in LFQ

The LFQ category page

  • K860142Uric Acid Reagent Set (Colorimetric)Sterling Diagnostics, Inc. · 19861 recall
  • K844075Uric Acid Reagent SetLivonia Diagnostics, Inc. · 1984
  • K812313Sandare Uric Acid ProcedureSandare Chemical Co., Inc. · 1981
  • K811764Uric Acid Reagent SetAnco Medical Reagents & Assoc. · 1981

https://510kreport.com/device/K860111 · printed Nov 4, 2026

Cite this page

510(k) Report. “K860111: Uric Acid Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860111

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026