ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS— 510(k) K033491

Name: FDA 510(k) clearance K033491
Creator: U.S. Food and Drug Administration
Published: 2004-09-01

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K033491 for ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS, Substantially Equivalent on 2004-09-01. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2003-11-04
Decision date: 2004-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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