Immunalysis Ethyl Alcohol Enzyme Assay
FDA 510(k) clearance K181553 · decided 2018-10-31
Clearance details
- K-number
- K181553
- Device name
- Immunalysis Ethyl Alcohol Enzyme Assay
- Applicant
- Immunalysis Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-06-13
- Decision date
- 2018-10-31
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- DIC
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Pomona, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.