FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
K Number: K142543
·
Decision May 11, 2015
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
45
Applicant Total
85
Review Days
243
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Basic Information
- Device Name
- Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
- K Number
- K142543
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2900
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACON Laboratories, Inc.
- Date Received
- September 10, 2014
- Decision Date
- May 11, 2015
- Product Code
- KQO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KQO | Automated Urinalysis System | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KQO), ordered by most recent decision date.
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