# Aalto Scientific, Ltd.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 35 (1982–2017): 35 510(k) clearances
- Product codes: JJY (19), JJX (9), JPK (1), GGN (1), JJR (1), GGP (1), JJT (1), MJX (1), GLK (1)
- Predicates its devices cite: 32 (25 its own); citations of its devices by later devices: 29 (25 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Biosite Incorporated: 1 (https://510kreport.com/company/biosite)
- Casco Standards: 1 (https://510kreport.com/company/casco-standards)
- Maine Standards Co.: 1 (https://510kreport.com/company/maine-standards)
- Cliniqa Corporation: 1 (https://510kreport.com/company/cliniqa)
- Richmond Diagnostics, Inc.: 1 (https://510kreport.com/company/richmond-diagnostics)

## Firms that cite its devices most
- Provalis Diagnostics, Ltd.: 1 (https://510kreport.com/company/provalis-diagnostics)
- Maine Standards Co.: 1 (https://510kreport.com/company/maine-standards)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)

## Its most-cited devices
- K042318: Audit Microcv General Chemistry Linearity Set (2004), cited by 12
- K130157: Audit Microcv Beta-Hydroxybutyric Acid Linearity Set (2013), cited by 3
- K101216: Audit Microcv Protein Linearity Set (2011), cited by 2
- K101427: Audit Microcv HS-CRP Linearity Set (2010), cited by 2
- K130762: Audit Microcv Therapeutic Drug (TDM) Linearity Set (2013), cited by 2
- K062668: Audit Microcv Immunoassay Linearity Set (2006), cited by 2

## Recent decisions
- K163629: Audit MicroControls Linearity FD Tumor Markers II (Mar 10, 2017)
- K161874: Audit MicroControls Linearity DROP LQ Blood Glucose (Aug 10, 2016)
- K143571: Audit MicroControls Linearity LQ Cystatin-C (Jan 23, 2015)
- K143573: Audit MicroControls Linearity FD Tumor Markers II (Jan 16, 2015)
- K143026: Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (Nov 21, 2014)
- K142978: Audit MicroControls Linearity LQ Special Diabetes (Nov 20, 2014)
- K130762: Audit Microcv Therapeutic Drug (TDM) Linearity Set (Apr 29, 2013)
- K130764: Audit Microcv Vitamin D Linearity Set (Apr 26, 2013)

Source page: https://510kreport.com/company/aalto-scientific