510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960785Substantially Equivalent

Lfs Lipogel Assay Kit

Zaxis, Inc., Hudson OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960785 is the FDA 510(k) clearance record for LFS LIPOGEL ASSAY KIT, a class I device, cleared for Zaxis, Inc. on under FDA product code JHO (Electrophoretic Separation, Lipoproteins). FDA records list one 510(k) clearance for Zaxis, Inc. As of , FDA records show no recalls naming K960785.

Clearance record

Decision date
Received
(190 days to decision)
Product code
JHO Electrophoretic Separation, Lipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Zaxis, Inc. 1890 Georgetown Rd., Hudson OH
510(k) summary
Summary
Third party review
No

Clearances, product code JHO

Trailing 12 months

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

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