510(k) K091653
- Device
- ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
- Applicant
- ARK DIAGNOSTICS,INC
- 510(k) number
- K091653
- Product code
- ORI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-02
- Date received
- 2009-06-09
- Regulation
- 862.3350
- Classification name
- Levetiracetam 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
Source Documents#
Other 510(k) Records For Product Code ORI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232522 | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | 2024-02-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary