Cleared Traditional

TAS HMT CONTROLS

K960234 · Cardiovascular Diagnostics, Inc. · Hematology
May 1996
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K960234 is an FDA 510(k) clearance for the TAS HMT 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 May 30, 1996, 134 days after receiving the submission on January 17, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K960234 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1996
Decision Date May 30, 1996
Days to Decision 134 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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