ASCENSIA BREEZE BLOOD GLUCOSE METER— 510(k) K024062
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K024062 for ASCENSIA BREEZE BLOOD GLUCOSE METER, Substantially Equivalent on 2003-03-03. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Recent devices under product code CGA
view allMore clearances from Bayer Corp.
view all- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- 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
- K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
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.