# Selfcare, Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 15 (1996–2000): 15 510(k) clearances
- Product codes: CGA (9), CEP (3), LCX (2), JQP (1)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 18 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Unipath, Ltd.: 4 (https://510kreport.com/company/unipath)
- Medisense, Inc.: 2 (https://510kreport.com/company/medisense)
- Bayer Corp.: 2 (https://510kreport.com/company/bayer)
- Heraeus Kulzer, Inc.: 1 (https://510kreport.com/company/heraeus-kulzer)

## Firms that cite its devices most
- ACON Laboratories, Inc.: 4 (https://510kreport.com/company/acon-laboratories)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Philosys, Inc.: 1 (https://510kreport.com/company/philosys)
- Inverness Medical Innovations, Inc.: 1 (https://510kreport.com/company/inverness-medical-innovations)
- Sein Electronics Co., Ltd.: 1 (https://510kreport.com/company/sein-electronics)
- Diagnostic Chemicals, Ltd.: 1 (https://510kreport.com/company/diagnostic-chemicals)
- Liberty Healthcare Group, Inc.: 1 (https://510kreport.com/company/liberty-healthcare-group)
- Abbott Diabetes Care, Inc.: 1 (https://510kreport.com/company/abbott-diabetes-care)

## Its most-cited devices
- K002134: One Touch Ultra Blood Glucose Monitoring System (2000), cited by 10
- K970707: Elect II Blood Glucose Monitoring System (1997), cited by 2
- K001427: Modification to Fasttake Compact Blood Glucose Monitoring System (2000), cited by 2
- K960436: Selfcare Early Pregnancy Test (1996), cited by 1
- K961985: Elect Blood Glucose Monitorig System (1996), cited by 1
- K990939: Fasttake Compact Blood Glucose Monitoring System (1999), cited by 1

## Recent decisions
- K002867: Inverness Medical Ovulation Predictor Test (Oct 12, 2000)
- K002134: One Touch Ultra Blood Glucose Monitoring System (Aug 7, 2000)
- K002049: Inverness Medical Early Pregnancy Test (Jul 27, 2000)
- K001427: Modification to Fasttake Compact Blood Glucose Monitoring System (Jun 2, 2000)
- K000583: Fasttake Compact Blood Glucose Monitoring System (Mar 17, 2000)
- K993632: Fasttake Compact Blood Glucose Monitoring System (Nov 12, 1999)
- K991480: Excel GE Blood Glucose Test Strips & Code Strip (Sep 17, 1999)
- K991386: Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick) (May 25, 1999)

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