AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL— 510(k) K951435
Substantially EquivalentAalto Scientific, Ltd.
FDA 510(k) clearance K951435 for AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL, Substantially Equivalent on 1995-05-02. Applicant: Aalto Scientific, Ltd.. Device class: 1.
Clearance details
- Applicant
- Aalto Scientific, Ltd.
- Product code
- Code JJR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vista, CA, US
Recent devices under product code JJR
view allMore clearances from Aalto Scientific, Ltd.
view all- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose
- K143571 — Audit MicroControls Linearity LQ Cystatin-C
- K143573 — Audit MicroControls Linearity FD Tumor Markers II
- K143026 — Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
Data sourced from openFDA. This site is unofficial and independent of the FDA.