WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180

• K Number: K932661
• Device Name: WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
• Manufacturer: WHATMAN SPECIALTY PRODUCTS, INC.
• Date Cleared: 1996-04-17 ( 1050 days)
• Product Code: PJC
• Regulation Number: 862.1675
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) "Substantially Equivalent" letter from the FDA regarding a "Whatman Body Fluid Collection Paper" (Whatman BFC 180). This document does not contain the information requested about acceptance criteria and device performance studies (e.g., sample size, expert qualifications, study methodologies, effect sizes for AI assistance).

The letter primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the general controls and regulatory requirements (e.g., registration, labeling, medical device reporting, good manufacturing practice) that the manufacturer must comply with.
• Providing contact information for regulatory guidance.

Therefore, I cannot extract the detailed information about acceptance criteria and study particulars from this document.

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.