PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY— 510(k) K010553
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K010553 for PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY, Substantially Equivalent on 2001-06-18. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- 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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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.