Aspirinworks Test Kit (11-DEHYDRO Thromboxane B2), Model 12136
FDA 510(k) K062025 · Corgenix, Inc.
510(k) numberK062025
Submission
- Device name
- Aspirinworks Test Kit (11-DEHYDRO Thromboxane B2), Model 12136
- Applicant
- Corgenix, Inc.
Broomfield, CO, US - Received
- July 18, 2006
- Decision date
- May 29, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBW – 11-Dehydro Thromboxane B2 Kit, Urinary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5700
- Specialty
- Hematology
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.
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Questions and answers
When was Aspirinworks Test Kit (11-DEHYDRO Thromboxane B2), Model 12136 cleared by the FDA?
Aspirinworks Test Kit (11-DEHYDRO Thromboxane B2), Model 12136 (K062025) received a 510(k) decision of Substantially Equivalent on May 29, 2007, 315 days after the submission was received.
What is the product code of K062025?
The FDA product code is OBW – 11-Dehydro Thromboxane B2 Kit, Urinary, a Class II (moderate risk) device regulated under 21 CFR 864.5700.