510(k) K153596
- Device
- ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
- Applicant
- ARK DIAGNOSTICS, INC.
- 510(k) number
- K153596
- Product code
- POX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-08-09
- Date received
- 2015-12-16
- Regulation
- 862.3645
- Classification name
- Enzyme Immunoassay, Oxcarbazepine Metabolite
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH C. KASPER
- Address
- 48089 Fremont Blvd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3005755244
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary