BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS— 510(k) K954921

Name: FDA 510(k) clearance K954921
Creator: U.S. Food and Drug Administration
Published: 1996-02-16

Substantially Equivalent

Becton Dickinson Diagnostic Instrument Systems

FDA 510(k) clearance K954921 for BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS, Substantially Equivalent on 1996-02-16. Applicant: Becton Dickinson Diagnostic Instrument Systems. Device class: 1.

Clearance details

Applicant: Becton Dickinson Diagnostic Instrument Systems
Product code: Code MDB
Device class: Class 1
Regulation: 21 CFR 866.2560
Advisory panel: Microbiology
Date received: 1995-10-26
Decision date: 1996-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MDB

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K222559 — BD BACTEC Myco/F Lytic Culture Vials2023-03-24
K222591 — BD BACTEC Plus Aerobic/F Culture Vials2023-03-24
K190405 — BACT/ALERT MP Reagent System2019-05-15
K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus2019-02-11

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K962210 — BACTEC 9050 SYSTEM1996-08-08
K946268 — BACTEC(R) 9000TB SYSTEM1996-05-21
K960827 — QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)1996-05-17

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.