Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )— 510(k) K142391
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K142391 for Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ), Substantially Equivalent on 2014-12-22. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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