AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5— 510(k) K100716
Substantially EquivalentAalto Scientific, Ltd.
FDA 510(k) clearance K100716 for AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5, Substantially Equivalent on 2011-06-23. Applicant: Aalto Scientific, Ltd.. Device class: 2.
Clearance details
- Applicant
- Aalto Scientific, Ltd.
- Product code
- Product code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.