N LATEX CRP MONO REAGENT— 510(k) K964687

Name: FDA 510(k) clearance K964687
Creator: U.S. Food and Drug Administration
Published: 1996-12-16

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K964687 for N LATEX CRP MONO REAGENT, Substantially Equivalent on 1996-12-16. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DCH
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 1996-09-17
Decision date: 1996-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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