BARD AND BTA TEST— 510(k) K964151

Name: FDA 510(k) clearance K964151
Creator: U.S. Food and Drug Administration
Published: 1997-04-16

Substantially Equivalent

Bard Diagnostic Sciences,Inc.

FDA 510(k) clearance K964151 for BARD AND BTA TEST, Substantially Equivalent on 1997-04-16. Applicant: Bard Diagnostic Sciences,Inc.. Device class: 2.

Clearance details

Applicant: Bard Diagnostic Sciences,Inc.
Product code: Code MMW
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1996-10-01
Decision date: 1997-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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