(97 days)
The DisChem™ Chemical Proportioning & Dispensing System, Aquarius model, for use exclusively with Cetlycide-G concentrate and diluent packaged specifically for the DisChem™ system, is intended for dispensing the Cetylcide-G use solution.
Not Found
This document is a FDA 510(k) clearance letter for the DisChem™ Chemical Proportioning and Dispensing System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a regulatory document confirming that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It states that the device can be marketed subject to general controls and other applicable regulations.
Therefore, I cannot provide the requested information based on the provided input. The prompt specifically asks about performance studies and acceptance criteria, none of which are detailed in this regulatory clearance letter.
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.