# Nova Biomedical Corp.

- Location (FDA's records): Walham, MA
- FDA decisions: 129 (1977–2026): 129 510(k) clearances
- Names in FDA's records: Nova Biomedical Corp. (89); Nova Biomedical Corporation (40)
- Product codes: CHL (28), JGS (21), PZI (10), JJY (8), CGA (7), JFP (6), NBW (6), CEM (4), GKF (3), CGL (3), KHP (3), JJX (2)
- 510(k) review time since 2016: median 120 days, against 140 for FDA's reviews in the same codes and years (4 of 10 faster)
- Predicates its devices cite: 55 (46 its own); citations of its devices by later devices: 63 (46 its own)
- Recalls linked to its devices: 30 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Diabetes Care, Inc.: 2 (https://510kreport.com/company/abbott-diabetes-care)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Abbott Rapid Diagnostics: 1 (https://510kreport.com/company/abbott-rapid-diagnostics)
- Home Diagnostics, Inc.: 1 (https://510kreport.com/company/home-diagnostics)
- Axis-Shield Poc AS: 1 (https://510kreport.com/company/axis-shield-poc)
- Kdk Corp.: 1 (https://510kreport.com/company/kdk)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Yellow Springs Instrument Co., Inc.: 1 (https://510kreport.com/company/yellow-springs-instrument)

## Firms that cite its devices most
- Avl Scientific Corp.: 5 (https://510kreport.com/company/avl-scientific)
- Apex BioTechnology Corp.: 4 (https://510kreport.com/company/apex-biotechnology)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Arkray, Inc.: 1 (https://510kreport.com/company/arkray)
- Taidoc Technology Corporation: 1 (https://510kreport.com/company/taidoc-technology)
- I-Sens, Inc.: 1 (https://510kreport.com/company/i-sens)
- Sendx Medical, Inc.: 1 (https://510kreport.com/company/sendx-medical)
- Radiometer Medicals Aps: 1 (https://510kreport.com/company/radiometer-medicals)

## Its most-cited devices
- K110648: Nova Stat Profile Phox Ultra Analyzer System (2011), cited by 9
- K091547: Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood Glucos (2010), cited by 7
- K181043: StatStrip Glucose Hospital Meter System (2018), cited by 4
- K070255: Nova Max Blood Glucose Monitor System, 90001,90002 (2007), cited by 4
- K874832: Nova Stat Profile 5 Analyzer + Quality Control (1988), cited by 3
- K132121: Statstrip Glucose Hospital Meter System (2014), cited by 3

## Recent decisions
- K251281: Nova Max Creat eGFR Monitoring System (Jan 21, 2026)
- K252206: Nova Allegro UACR Assay, Nova Allegro Analyzer (Jan 9, 2026)
- K221326: Nova Allegro HbA1c Assay, Nova Allegro Analyzer (Nov 22, 2024)
- K221813: Nova Allegro UACR Assay, Nova Allegro Analyzer (Nov 19, 2024)
- K232075: StatStrip Glucose Hospital Meter System (Feb 23, 2024)
- K221900: Stat Profile Prime Plus Analyzer System (Sep 29, 2023)
- K203549: Nova Primary Glucose Analyzer System (Oct 18, 2022)
- K200403: Stat Profile Prime Plus Analyzer System (Apr 14, 2020)

Source page: https://510kreport.com/company/nova-biomedical