Cleared Traditional

1400 SERIES EVIDENCE COLLECTION KIT

K896373 · Transidyne General Corp. · Pathology
Feb 1990
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K896373 is an FDA 510(k) clearance for the 1400 SERIES EVIDENCE COLLECTION KIT, a Tubes, Vacuum Sample, With Anticoagulant (Class II — Special Controls, product code GIM), submitted by Transidyne General Corp. (Ann Arbor, US). The FDA issued a Cleared decision on February 26, 1990, 112 days after receiving the submission on November 6, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K896373 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1989
Decision Date February 26, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code GIM — Tubes, Vacuum Sample, With Anticoagulant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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