LASER PREALBUMIN TEST— 510(k) K851912

Name: FDA 510(k) clearance K851912
Creator: U.S. Food and Drug Administration
Published: 1985-06-21

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K851912 for LASER PREALBUMIN TEST, Substantially Equivalent on 1985-06-21. Applicant: Behring Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1985-05-01
Decision date: 1985-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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