ANA SENSITIVITY/SPECIFICITY CONTROL— 510(k) K841776

Name: FDA 510(k) clearance K841776
Creator: U.S. Food and Drug Administration
Published: 1984-06-22

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K841776 for ANA SENSITIVITY/SPECIFICITY CONTROL, Substantially Equivalent on 1984-06-22. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1984-04-30
Decision date: 1984-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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