BENACEL, MODELS C-001, C-002 AND C-005

• K Number: K080532
• Device Name: BENACEL, MODELS C-001, C-002 AND C-005
• Manufacturer: UNICARE BIOMEDICAL, INC.
• Date Cleared: 2008-11-12 ( 260 days)
• Product Code: QSY
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding an administrative change to a previous substantial equivalence determination for a device called "Benacel®".

This letter does not contain any information about:

• Acceptance criteria for the device's performance.
• Any study that proves the device meets acceptance criteria.
• Details about sample sizes, data provenance, expert qualifications, ground truth, or study methodologies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Regulation Number and Section

N/A