Emit II Plus Oxycodone Assay
FDA 510(k) clearance K172910 · decided 2017-10-18
Clearance details
- K-number
- K172910
- Device name
- Emit II Plus Oxycodone Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-25
- Decision date
- 2017-10-18
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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