510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811342Substantially Equivalent

Reagent Strips for Urinalysis

Miles Laboratories, Inc., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811342 is the FDA 510(k) clearance record for REAGENT STRIPS FOR URINALYSIS, a class I device, cleared for Miles Laboratories, Inc. on under FDA product code JRE (Refractometer For Clinical Use). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K811342.

Clearance record

Decision date
Received
(112 days to decision)
Product code
JRE Refractometer For Clinical Use
Regulation
21 CFR 862.2800
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Miles Laboratories, Inc. 1127 Myrtle St., Elkhart IN
Third party review
No

Clearances, product code JRE

Trailing 12 months

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

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