VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR

• K Number: K081929
• Device Name: VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
• Manufacturer: GREINER BIO-ONE NORTH AMERICA, INC.
• Date Cleared: 2008-12-16 ( 162 days)
• Product Code: JKA
• Regulation Number: 862.1675
• Type: Special
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

VACUETTE® Blood Collection Tubes with Clot Activator, Gel Separator, and Standard Stopper (16 x 100 mm, 8 mL) are used to collect, transport and process blood for testing serum in the clinical laboratory. In addition, the tubes are suitable for therapeutic drug monitoring (TDM).

Device Description

Greiner VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8 mL)

AI/ML Overview

This document is an FDA 510(k) clearance letter for a blood collection tube. It does not contain information about the acceptance criteria or a study proving a device meets acceptance criteria in the context of an AI-powered medical device.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Regulation Number and Section

§ 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.