ARK EDDP Assay
FDA 510(k) clearance K182779 · decided 2018-11-21
Clearance details
- K-number
- K182779
- Device name
- ARK EDDP Assay
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-01
- Decision date
- 2018-11-21
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- DJR
- Device class
- 2
- Regulation number
- 862.3620
- 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.