N ANTISERUM TO HUMAN ALBUMIN— 510(k) K972929

Name: FDA 510(k) clearance K972929
Creator: U.S. Food and Drug Administration
Published: 1997-10-20

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K972929 for N ANTISERUM TO HUMAN ALBUMIN, Substantially Equivalent on 1997-10-20. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 1997-08-08
Decision date: 1997-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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