510(k) K101574
- Device
- ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
- Applicant
- ARK DIAGNOSTICS,INC
- 510(k) number
- K101574
- Product code
- OTF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-11-23
- Date received
- 2010-06-07
- Regulation
- 862.3350
- Classification name
- Gabapentin Assay
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHNNY VALDEZ
- Address
- 1190 Bordeaux Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3005755244
- 3005360469
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary