BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K022580
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K022580 for BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2002-10-09. Applicant: Becton, Dickinson & CO. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson & CO
- 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
- Franklin Lakes, NJ, US
Recent devices under product code CGA
view allMore clearances from Becton, Dickinson & CO
view all- K160164 — BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
- K160161 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- K141474 — BECTON DICKINSON INTELLIPORT SYSTEM
- K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
- K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
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.