Cleared Traditional

SAMPLOK

K000777 · Itl Corporation Pty, Ltd. · Chemistry
Apr 2000
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K000777 is an FDA 510(k) clearance for the SAMPLOK, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Itl Corporation Pty, Ltd. (Rockville, US). The FDA issued a Cleared decision on April 11, 2000, 33 days after receiving the submission on March 9, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K000777 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2000
Decision Date April 11, 2000
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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