510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852611Substantially Equivalent

Test Urobilinogen in Urine & Leukocytes in Urine

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

K852611 is the FDA 510(k) clearance record for TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE, a class I device, cleared for Miles Laboratories, Inc. on under FDA product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K852611.

Clearance record

Decision date
Received
(76 days to decision)
Product code
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Regulation
21 CFR 862.1785
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Miles Laboratories, Inc. 1127 Myrtle St., Elkhart IN
Third party review
No

Clearances, product code CDM

Trailing 12 months

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

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