Who is the manufacturer of SAMPLOK?

Itl Corporation Pty, Ltd. submitted the Traditional clearance for SAMPLOK (K000777).

What is the FDA product code for SAMPLOK?

JKA. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for SAMPLOK?

510(k) clearance (submission type: Traditional).

SAMPLOK

K000777 · Itl Corporation Pty, Ltd. · JKA · Apr 11, 2000 · Clinical Chemistry

Device Facts

Record ID	K000777
Device Name	SAMPLOK
Applicant	Itl Corporation Pty, Ltd.
Product Code	JKA · Clinical Chemistry
Decision Date	Apr 11, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.