BACTEC MGIT 960 PZA KIT— 510(k) K021582
Substantially EquivalentBecton, Dickinson & CO
FDA 510(k) clearance K021582 for BACTEC MGIT 960 PZA KIT, Substantially Equivalent on 2002-07-13. 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 →
Recalls naming K021582
K-number listed on FDA's recall record- Z-2023-2025 — BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
- Z-2686-2024 — BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021582.
Data sourced from openFDA. This site is unofficial and independent of the FDA.