SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM— 510(k) K960053

Substantially Equivalent

Selfcare, Inc.

FDA 510(k) clearance K960053 for SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM, Substantially Equivalent on 1996-06-28. Applicant: Selfcare, Inc..

Clearance details

Applicant: Selfcare, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1996-01-04
Decision date: 1996-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.