510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860143Substantially Equivalent

Urine Diluent-for Use with Ion Selective Electrode

Reagent Laboratory, Inc., Louisville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860143 is the FDA 510(k) clearance record for URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE, a class I device, cleared for Reagent Laboratory, Inc. on under FDA product code JJP (Electrode, Ion Selective (Non-Specified)). FDA records list 19 510(k) clearances for Reagent Laboratory, Inc., from to . As of , FDA records show no recalls naming K860143.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JJP Electrode, Ion Selective (Non-Specified)
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Reagent Laboratory, Inc. 300 E. Ottawa Ave., Louisville KY
Third party review
No

Clearances, product code JJP

Trailing 12 months

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

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