510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091455Substantially Equivalent

Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model Dz113c-X, Diazyme Liquid Stable Enzymatic Potassium Assay Cal

Diazyme Laboratories, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K091455 is the FDA 510(k) clearance record for DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL, a class II device, cleared for Diazyme Laboratories on under FDA product code MZV (Test, System, Potassium, Enzymatic Method). FDA records list 52 510(k) clearances for Diazyme Laboratories, from to . As of , FDA records show no recalls naming K091455.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MZV Test, System, Potassium, Enzymatic Method
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diazyme Laboratories 12889 Gregg Ct., Poway CA
510(k) summary
Statement
Third party review
No

Clearances, product code MZV

Trailing 12 months

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

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