510(k) K062025
- Device
- ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
- Applicant
- CORGENIX, INC.
- 510(k) number
- K062025
- Product code
- OBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-05-29
- Date received
- 2006-07-18
- Regulation
- 864.5700
- Classification name
- 11-dehydro Thromboxane B2 Kit, Urinary
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KIMBERLY N HASSLER
- Address
- 11575 Main St. Suite 400 Broomfield CO US 80020 80020
FDA Registration Numbers#
- 1721937
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary