Cleared Special

K030740 - MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
(FDA 510(k) Clearance)

K030740 · Roche Diagnostics Corp. · Hematology

Apr 2003

Decision

22d

Days

Class 2

Risk

K030740 is an FDA 510(k) clearance for the MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on April 1, 2003, 22 days after receiving the submission on March 10, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K030740 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2003
Decision Date	April 01, 2003
Days to Decision	22 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF