BACTEC 9050 SYSTEM— 510(k) K962210

Name: FDA 510(k) clearance K962210
Creator: U.S. Food and Drug Administration
Published: 1996-08-08

Substantially Equivalent

Becton Dickinson Diagnostic Instrument Systems

FDA 510(k) clearance K962210 for BACTEC 9050 SYSTEM, Substantially Equivalent on 1996-08-08. 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: 1996-06-10
Decision date: 1996-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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K960827 — QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)1996-05-17
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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.