510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K032012Substantially Equivalent

Homocysteine Microtiter Plate Assay

Diazyme Laboratories, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032012 is the FDA 510(k) clearance record for HOMOCYSTEINE MICROTITER PLATE ASSAY, a class II device, cleared for Diazyme Laboratories on under FDA product code LPS (Urinary Homocystine (Nonquantitative) Test System). FDA records list 52 510(k) clearances for Diazyme Laboratories, from to . As of , FDA records show no recalls naming K032012.

Clearance record

Decision date
Received
(65 days to decision)
Product code
LPS Urinary Homocystine (Nonquantitative) Test System
Regulation
21 CFR 862.1377
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diazyme Laboratories 3722 Ave. Sausalito, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LPS

Trailing 12 months

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

FDA records show no clearances under product code LPS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LPS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260