Cleared Traditional

CA-1000 AUTOMATED COAGULATION ANALYZER

K931149 · Toa Medical Electronics USA, Inc. · Hematology
Nov 1993
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K931149 is an FDA 510(k) clearance for the CA-1000 AUTOMATED COAGULATION ANALYZER, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on November 3, 1993, 240 days after receiving the submission on March 8, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K931149 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1993
Decision Date November 03, 1993
Days to Decision 240 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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