BACTEC MGIT 960 SIRE KITS— 510(k) K014123
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K014123 for BACTEC MGIT 960 SIRE KITS, Substantially Equivalent on 2002-04-19. Applicant: Becton, Dickinson & CO. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson & CO
- Product code
- Code MJA
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
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Adverse events under product code MJA
product code MJA- Malfunction
- 827
- Total
- 827
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.