CDC ANAEROBE BLOOD AGAR— 510(k) K803025
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K803025 for CDC ANAEROBE BLOOD AGAR, Substantially Equivalent on 1980-12-22. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Product code
- Code JSG
- Device class
- Class 1
- Regulation
- 21 CFR 866.2300
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code JSG
view allMore clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic
view allAdverse events under product code JSG
product code JSG- Malfunction
- 817
- Total
- 817
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 K803025
K-number listed on FDA's recall record- Z-0975-2015 — CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic and aerobic bacteria.
- Z-1334-2013 — BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K803025.
Data sourced from openFDA. This site is unofficial and independent of the FDA.