Cleared Traditional

THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS

K961814 · Cardiovascular Diagnostics, Inc. · Hematology
Aug 1996
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K961814 is an FDA 510(k) clearance for the THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS, a Plasma, Control, Normal (Class II — Special Controls, product code GIZ), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on August 13, 1996, 95 days after receiving the submission on May 10, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K961814 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1996
Decision Date August 13, 1996
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIZ — Plasma, Control, Normal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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