SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)

• K Number: K936240
• Device Name: SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
• Manufacturer: SUDORMED, INC.
• Date Cleared: 1996-03-19 ( 810 days)
• Product Code: JKA
• Regulation Number: 862.1675
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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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.