Cleared Traditional

TransFix/EDTA Vacuum Blood Collection Tubes

K162723 · Caltag Medsystems, Ltd. · Immunology
Jun 2017
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K162723 is an FDA 510(k) clearance for the TransFix/EDTA Vacuum Blood Collection Tubes, a Tubes, Vacuum Sample, With Anticoagulant (Class II — Special Controls, product code GIM), submitted by Caltag Medsystems, Ltd. (Buckingham, GB). The FDA issued a Cleared decision on June 22, 2017, 266 days after receiving the submission on September 29, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K162723 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2016
Decision Date June 22, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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