Cleared Traditional

THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

K981178 · Cardiovascular Diagnostics, Inc. · Hematology
Apr 1998
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K981178 is an FDA 510(k) clearance for the THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on April 27, 1998, 26 days after receiving the submission on April 1, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K981178 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1998
Decision Date April 27, 1998
Days to Decision 26 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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