ASCENSIA DEX 2 DIABETES CARE SYSTEM— 510(k) K023584
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K023584 for ASCENSIA DEX 2 DIABETES CARE SYSTEM, Substantially Equivalent on 2002-11-20. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- 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
- Special
- Location
- Elkhart, IN, US
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More clearances from Bayer Corp.
view all- K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER
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- K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Adverse 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.