ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
FDA 510(k) clearance K101574 · decided 2010-11-23
Clearance details
- K-number
- K101574
- Device name
- ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-07
- Decision date
- 2010-11-23
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- OTF
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.