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FDA 510(k)

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136

K-Number: K062025 · 2007-05-29

ApplicantCorgenix, Inc.
Decision Date2007-05-29
Product CodeOBW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 is the device name listed in this FDA 510(k) record. The listed applicant is Corgenix, Inc.. It received FDA 510(k) clearance on 2007-05-29 under 510(k) number K062025. The device is classified under product code OBW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136?

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 is a medical device that received FDA 510(k) clearance on 2007-05-29. The listed applicant is Corgenix, Inc.. The 510(k) number is K062025.

When did ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 receive FDA 510(k) clearance?

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 received FDA 510(k) clearance on 2007-05-29, under 510(k) number K062025.

Who is the listed applicant for ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136?

The FDA 510(k) record lists Corgenix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136?

The FDA product code for ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 is OBW.

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Other records listing Corgenix, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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