LogoFDA 510(k) Search
K Number
K000777

Validate with FDA (Live)

Device Name
SAMPLOK
Manufacturer
ITL CORPORATION, PTY LTD.
Date Cleared
2000-04-11

(33 days)

Product Code
JKA
Regulation Number
862.1675
Type
Traditional
Panel
Clinical Chemistry
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K021941
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 862.1675 Blood specimen collection device.

(a)
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.(b)
Classification. Class II.