Cleared Traditional

TAS ANALYZER, MODEL 1009

K990566 · Cardiovascular Diagnostics, Inc. · Hematology
May 1999
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K990566 is an FDA 510(k) clearance for the TAS ANALYZER, MODEL 1009, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on May 14, 1999, 81 days after receiving the submission on February 22, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K990566 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1999
Decision Date May 14, 1999
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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