Cleared Traditional

(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT

K994194 · Cardiovascular Diagnostics, Inc. · Hematology
Mar 2000
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K994194 is an FDA 510(k) clearance for the (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT, a Activated Whole Blood Clotting Time (Class II — Special Controls, product code JBP), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on March 28, 2000, 106 days after receiving the submission on December 13, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7140.

Submission Details

510(k) Number K994194 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1999
Decision Date March 28, 2000
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBP — Activated Whole Blood Clotting Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7140

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