Cleared Traditional

DS30 HCY BLOOD COLLECTION TUBES

K012152 · Drew Scientific , Ltd. · Chemistry
Sep 2001
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K012152 is an FDA 510(k) clearance for the DS30 HCY BLOOD COLLECTION TUBES, a Tubes, Vacuum Sample, With Anticoagulant (Class II — Special Controls, product code GIM), submitted by Drew Scientific , Ltd. (Barrow In Furness, GB). The FDA issued a Cleared decision on September 18, 2001, 69 days after receiving the submission on July 11, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K012152 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2001
Decision Date September 18, 2001
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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