N PROTEIN STANDARD PLASMA (HUMAN)— 510(k) K880356

Name: FDA 510(k) clearance K880356
Creator: U.S. Food and Drug Administration
Published: 1988-04-07

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K880356 for N PROTEIN STANDARD PLASMA (HUMAN), Substantially Equivalent on 1988-04-07. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1988-01-26
Decision date: 1988-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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