BD MAX STAPHSR ASSAY, INSTRUMENT— 510(k) K132822

Name: FDA 510(k) clearance K132822
Creator: U.S. Food and Drug Administration
Published: 2013-11-26

Substantially Equivalent

Geneohm Sciences Canada, Inc. (Bd Diagnostics)

FDA 510(k) clearance K132822 for BD MAX STAPHSR ASSAY, INSTRUMENT, Substantially Equivalent on 2013-11-26. Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics). Device class: 2.

Clearance details

Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2013-09-09
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K132822

K-number listed on FDA's recall record

Z-2332-2019 — Kit BD Max StaphSR; Catalog # 443418Class II·Terminated·Becton Dickinson & Co.·20190717
Z-2333-2019 — Kit BD Max StaphSR; Catalog # 443419Class II·Terminated·Becton Dickinson & Co.·20190717

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132822.

Data sourced from openFDA. This site is unofficial and independent of the FDA.