Cleared Traditional

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

K163073 · Sol-Millennium Medical, Inc. · Chemistry
May 2017
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K163073 is an FDA 510(k) clearance for the Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Sol-Millennium Medical, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on May 19, 2017, 198 days after receiving the submission on November 2, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K163073 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2016
Decision Date May 19, 2017
Days to Decision 198 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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