# Medisense, Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 15 (1990–1999): 15 510(k) clearances
- Product codes: CGA (11), LCP (1), LDP (1), CHH (1), CEM (1)
- Predicates its devices cite: 27 (17 its own); citations of its devices by later devices: 31 (17 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boehringer Mannheim Corp.: 4 (https://510kreport.com/company/boehringer-mannheim)
- Gds Technology, LLC: 1 (https://510kreport.com/company/gds-technology)
- Sigma Chemical Co.: 1 (https://510kreport.com/company/sigma-chemical)
- Travenol Laboratories, S.A.: 1 (https://510kreport.com/company/travenol-laboratories)
- Flexsite Diagnostics, Inc.: 1 (https://510kreport.com/company/flexsite-diagnostics)
- Awareness Technology, Inc.: 1 (https://510kreport.com/company/awareness-technology)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)

## Firms that cite its devices most
- Abbott Laboratories: 7 (https://510kreport.com/company/abbott-laboratories)
- Selfcare, Inc.: 2 (https://510kreport.com/company/selfcare)
- Abbott Diabetes Care, Inc.: 2 (https://510kreport.com/company/abbott-diabetes-care)
- Eps Bio Technology Corp.: 1 (https://510kreport.com/company/eps-bio-technology)
- Bionostics, Inc.: 1 (https://510kreport.com/company/bionostics)
- Liberty Healthcare Group, Inc.: 1 (https://510kreport.com/company/liberty-healthcare-group)

## Its most-cited devices
- K945887: Precision Q I D Blood Glucose Test Strips (1995), cited by 6
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST (1999), cited by 6
- K962295: Precision Qid Blood Glucose Test Strip (1996), cited by 4
- K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip (1997), cited by 4
- K944195: Quickpro Blood Glucose Testing System (1995), cited by 3
- K963676: Precision G Blood Glucose Testing System (1997), cited by 3

## Recent decisions
- K983504: Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-Ketone Test ST (Jul 9, 1999)
- K982303: Precision PCX Point of Care Management System  , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST (Dec 8, 1998)
- K983253: Precision A1C Home HBA1C Sample Collection Kit (Nov 20, 1998)
- K971812: Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip (Aug 8, 1997)
- K963676: Precision G Blood Glucose Testing System (Feb 20, 1997)
- K962295: Precision Qid Blood Glucose Test Strip (Jul 26, 1996)
- K961337: Exactech RSG Blood Glucose Testing System (Jun 21, 1996)
- K952279: Precision Link Blood Glucose Data Management System (Jun 14, 1995)

Source page: https://510kreport.com/company/medisense