510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860538Substantially Equivalent

Right-Day Urinary Lh (Eia)

Leeco Diagnostics, Inc., Southfield MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860538 is the FDA 510(k) clearance record for RIGHT-DAY URINARY LH (EIA), a class I device, cleared for Leeco Diagnostics, Inc. on under FDA product code CEP (Radioimmunoassay, Luteinizing Hormone). FDA records list 49 510(k) clearances for Leeco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K860538.

Clearance record

Decision date
Received
(167 days to decision)
Product code
CEP Radioimmunoassay, Luteinizing Hormone
Regulation
21 CFR 862.1485
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Leeco Diagnostics, Inc. 21705 Evergreen, Southfield MI
Third party review
No

Clearances, product code CEP

Trailing 12 months

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

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