VACUETTE WITH PPACK

• K Number: K002777
• Device Name: VACUETTE WITH PPACK
• Manufacturer: GREINER VACUETTE NORTH AMERICA, INC.
• Date Cleared: 2000-10-05 ( 29 days)
• Product Code: JKA
• Regulation Number: 862.1675
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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Summary

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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.