510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891095Substantially Equivalent

Vis-Disk Hcg (Eia) Lyophilized Jpl-044M

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

K891095 is the FDA 510(k) clearance record for VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M, a class II device, cleared for Leeco Diagnostics, Inc. on under FDA product code DHA (System, Test, Human Chorionic Gonadotropin). FDA records list 49 510(k) clearances for Leeco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K891095.

Clearance record

Decision date
Received
(106 days to decision)
Product code
DHA System, Test, Human Chorionic Gonadotropin
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Leeco Diagnostics, Inc. 21705 Evergreen, Southfield MI
Third party review
No

Clearances, product code DHA

Trailing 12 months

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

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