IQ TT4 ASSAY— 510(k) K931295

Name: FDA 510(k) clearance K931295
Creator: U.S. Food and Drug Administration
Published: 1993-07-20

Substantially Equivalent

Becton Dickinson Advanced Diagnostics

FDA 510(k) clearance K931295 for IQ TT4 ASSAY, Substantially Equivalent on 1993-07-20. Applicant: Becton Dickinson Advanced Diagnostics. Device class: 2.

Clearance details

Applicant: Becton Dickinson Advanced Diagnostics
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1993-03-15
Decision date: 1993-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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