ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM— 510(k) K971998

Name: FDA 510(k) clearance K971998
Creator: U.S. Food and Drug Administration
Published: 1997-08-29

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K971998 for ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM, Substantially Equivalent on 1997-08-29. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1997-05-30
Decision date: 1997-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K971998

K-number listed on FDA's recall record

Z-2114-2013 — ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.Class II·Terminated·Siemens Healthcare Diagnostics·20130626

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971998.

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