Cleared Traditional

HEPARIN MANAGEMENT TEST CARD; HMT CARD

K943283 · Cardiovascular Diagnostics, Inc. · Hematology
May 1995
Decision
307d
Days
Class 2
Risk

About This 510(k) Submission

K943283 is an FDA 510(k) clearance for the HEPARIN MANAGEMENT TEST CARD; HMT CARD, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on May 10, 1995, 307 days after receiving the submission on July 7, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K943283 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1994
Decision Date May 10, 1995
Days to Decision 307 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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