Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
FDA 510(k) clearance K142391 · decided 2014-12-22
Clearance details
- K-number
- K142391
- Device name
- Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-27
- Decision date
- 2014-12-22
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.