VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY— 510(k) K101234

Name: FDA 510(k) clearance K101234
Creator: U.S. Food and Drug Administration
Published: 2011-08-25

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K101234 for VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY, Substantially Equivalent on 2011-08-25. Applicant: Ventana Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code OWF
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2010-05-03
Decision date: 2011-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K101234

K-number listed on FDA's recall record

Z-3010-2018 — VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.Class I·Terminated·Ventana Medical Systems Inc·20180802

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101234.

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