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

11-Dehydro Thromboxane B2 Kit, Urinary

21 CFR 864.5700 / Hematology
FDA source (opens on fda.gov)

OBW is the FDA product code for 11-Dehydro Thromboxane B2 Kit, Urinary, a class II device type, regulated under 21 CFR 864.5700. FDA's definition for this code 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. For professional use only". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OBW
Device name
11-Dehydro Thromboxane B2 Kit, Urinary
FDA definition
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. For professional use only.
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code OBW

By decision year
1 clearance under product code OBW with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OBW by decision year
YearClearances
20071

Applicants with the most clearances

Product code OBW
Applicants holding the most 510(k) clearances under product code OBW
ApplicantClearances
Corgenix, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code