BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA— 510(k) K921133

Name: FDA 510(k) clearance K921133
Creator: U.S. Food and Drug Administration
Published: 1992-04-22

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K921133 for BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA, Substantially Equivalent on 1992-04-22. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code MDB
Device class: Class 1
Regulation: 21 CFR 866.2560
Advisory panel: Microbiology
Date received: 1992-03-10
Decision date: 1992-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus2019-02-11

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Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.