BD Kiestra IdentifA— 510(k) K191964

Substantially Equivalent

Becton, Dickinson and Company

FDA 510(k) clearance K191964 for BD Kiestra IdentifA, Substantially Equivalent on 2021-11-03. Applicant: Becton, Dickinson and Company. Device class: 2.

Clearance details

Applicant
Becton, Dickinson and Company
Product code
Code QQV
Device class
Class 2
Regulation
21 CFR 866.3378
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, MD, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code QQV

product code QQV
Other
1
Total
1

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.