BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial— 510(k) K161810
Substantially EquivalentBecton Dickinson
FDA 510(k) clearance K161810 for BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial, Substantially Equivalent on 2017-02-09. Applicant: Becton Dickinson. Device class: 1.
Clearance details
- Applicant
- Becton Dickinson
- Product code
- Code MDB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code MDB
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- K041478 — BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
- K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
Adverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
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.