510(k) Report

510(k) · Cleared

Cleared

Urine Diluent-for Use with Ion Selective Electrode

K860143510(k) TraditionalCleared Feb 10, 198626-day reviewClass I21 CFR 862.2050

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

Reagent Laboratory, Inc. · JJP Electrode, Ion Selective (Non-Specified)

Cleared on Feb 10, 1986 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 10, 1986
Review
26 days
Class
Class I
Product code
JJP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K860143Source: 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 JJP? 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 JJP devices

JJP Electrode, Ion Selective (Non-Specified): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJP

FDA has decided no JJP device since 2007.

Median 510(k) review, days · JJP

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

Recalls per year · JJP

No recall names JJP since 2007.

Adverse event reports per year · JJP

No MAUDE report names JJP since 2007.

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—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Reagent Laboratory, Inc.

19 FDA decisions under this applicant name. See the company

  • K863502Solution B- NA 50MEQ/L, K 40 Meq/LReagent Laboratory, Inc. · 1986
  • K863503HemolyseReagent Laboratory, Inc. · 1986
  • K863550Potassium Hydroxide 10% W/VReagent Laboratory, Inc. · 1986
  • K842982Formalin BufferedReagent Laboratory, Inc. · 1984
  • K843050Gram StainReagent Laboratory, Inc. · 1984

Recent decisions in JJP

The JJP category page

  • K900280Centriprep 100Amicon, Inc. · 1990
  • K863438Nova II Sodium/Potassium/Lithium AnalyzerNova Biomedical Corp. · 1986

https://510kreport.com/device/K860143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860143: Urine Diluent-for Use with Ion Selective Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860143

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