Cleared Traditional

PROTHROMBIN TIME TEST CARD

K954625 · Cardiovascular Diagnostics, Inc. · Hematology
Mar 1996
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K954625 is an FDA 510(k) clearance for the PROTHROMBIN TIME TEST CARD, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on March 11, 1996, 166 days after receiving the submission on September 27, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K954625 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1995
Decision Date March 11, 1996
Days to Decision 166 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750