510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203136Substantially Equivalent

Diazyme PLAC® Test for Lp-PLA2 Activity

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

K203136 is the FDA 510(k) clearance record for Diazyme PLAC® Test for Lp-PLA2 Activity, a class II device, cleared for Diazyme Laboratories, Inc. on under FDA product code NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2). FDA's definition for product code NOE reads: "The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including...". FDA records list 52 510(k) clearances for Diazyme Laboratories, Inc., from to . As of , FDA records show no recalls naming K203136.

Clearance record

Decision date
Received
(290 days to decision)
Product code
NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Regulation
21 CFR 866.5600
Device class
Class II
Review panel
Immunology
Applicant
Diazyme Laboratories, Inc. 12889 Gregg Ct., Poway CA
510(k) summary
Statement
Third party review
No

Clearances, product code NOE

Trailing 12 months

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

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