MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM— 510(k) K022182
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K022182 for MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2002-09-09. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
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- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
More clearances from Abbott Laboratories
view allAdverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
Source: openFDA MAUDE database, through . 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.