TINA-QUANT D-DIMER TEST SYSTEM— 510(k) K011143

Name: FDA 510(k) clearance K011143
Creator: U.S. Food and Drug Administration
Published: 2001-05-29

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K011143 for TINA-QUANT D-DIMER TEST SYSTEM, Substantially Equivalent on 2001-05-29. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2001-04-13
Decision date: 2001-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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