N LATEX IGM— 510(k) K032014

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K032014 for N LATEX IGM, Substantially Equivalent on 2003-08-07. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2003-06-30
Decision date: 2003-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dade Behring, Inc.

Recalls naming K032014

K-number listed on FDA's recall record

Z-1289-2015 — N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.Class III·Terminated·Siemens Healthcare Diagnostics, Inc.·20150115

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032014.

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