Cleared Special

SAMPLOK LUER KIT

K021941 · Itl Corporation Pty, Ltd. · Chemistry
Jul 2002
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K021941 is an FDA 510(k) clearance for the SAMPLOK LUER KIT, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Itl Corporation Pty, Ltd. (Fyshwick, Canberra Act, AU). The FDA issued a Cleared decision on July 2, 2002, 19 days after receiving the submission on June 13, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K021941 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2002
Decision Date July 02, 2002
Days to Decision 19 days
Submission Type Special
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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