510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062025Substantially Equivalent

Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136

Corgenix, Inc., Broomfield CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062025 is the FDA 510(k) clearance record for ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136, a class II device, cleared for Corgenix, Inc. on under FDA product code OBW (11-Dehydro Thromboxane B2 Kit, Urinary). FDA's definition for product code OBW reads: "The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion...". FDA records list 23 510(k) clearances for Corgenix, Inc., from to . As of , FDA records show no recalls naming K062025.

Clearance record

Decision date
Received
(315 days to decision)
Product code
OBW 11-Dehydro Thromboxane B2 Kit, Urinary
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Applicant
Corgenix, Inc. 11575 Main St. Suite 400, Broomfield CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBW

Trailing 12 months

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

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