510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101853Substantially Equivalent

Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

Diadexus, Inc., South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101853 is the FDA 510(k) clearance record for PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115, a class II device, cleared for Diadexus, 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 7 510(k) clearances for Diadexus, Inc., from to . As of , FDA records show no recalls naming K101853.

Clearance record

Decision date
Received
(186 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
Diadexus, Inc. 343 Oyster Pt. Blvd., South San Francisco CA
510(k) summary
Summary PDF
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