ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
FDA 510(k) clearance K153596 · decided 2016-08-09
Clearance details
- K-number
- K153596
- Device name
- ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-16
- Decision date
- 2016-08-09
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- POX
- Device class
- 2
- Regulation number
- 862.3645
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.