MISSION SALIVA ALCOHOL TEST STRIP
FDA 510(k) clearance K093879 · decided 2010-08-06
Clearance details
- K-number
- K093879
- Device name
- MISSION SALIVA ALCOHOL TEST STRIP
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-18
- Decision date
- 2010-08-06
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- DIC
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.