Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System— 510(k) K163406
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K163406 for Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System, Substantially Equivalent on 2017-07-11. Applicant: ACON Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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