510(k) K101305
- Device
- ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
- Applicant
- ARK DIAGNOSTICS,INC
- 510(k) number
- K101305
- Product code
- ORH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-10-29
- Date received
- 2010-05-10
- Regulation
- 862.3350
- Classification name
- Lamotrigine 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#
- 3010939897
- 3005755244
Source Documents#
Other 510(k) Records For Product Code ORH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | Seradyn, Inc. | 2007-01-12 |
Legacy Summary#
summary
FDA Review#
Decision Summary