Cleared Traditional

TOA MEDICAL ELECTRONICS CA-5000

K933886 · Toa Medical Electronics USA, Inc. · Hematology
Jan 1994
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K933886 is an FDA 510(k) clearance for the TOA MEDICAL ELECTRONICS CA-5000, 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 January 27, 1994, 170 days after receiving the submission on August 10, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K933886 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1993
Decision Date January 27, 1994
Days to Decision 170 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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