ACTIM PROM AND CONTROLS— 510(k) K061886
Substantially EquivalentMedix Biochemica
FDA 510(k) clearance K061886 for ACTIM PROM AND CONTROLS, Substantially Equivalent on 2007-01-25. Applicant: Medix Biochemica. Device class: 1.
Clearance details
- Applicant
- Medix Biochemica
- Product code
- Code OAM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1550
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code OAM
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