LZI Oxycodone III Enzyme Immunoassay
FDA 510(k) clearance K202007 · decided 2020-09-17
Clearance details
- K-number
- K202007
- Device name
- LZI Oxycodone III Enzyme Immunoassay
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-21
- Decision date
- 2020-09-17
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- DJG
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.