ACCUFLEX

Station, Pipetting And Diluting, For Clinical Use

MICROMEDIC SYSTEMS

The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Accuflex.

Pre-market Notification Details

• Device ID: K834590
• 510k Number: K834590
• Device Name: ACCUFLEX
• Classification: Station, Pipetting And Diluting, For Clinical Use
• Applicant: MICROMEDIC SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JQW
• CFR Regulation Number: 862.2750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-12-29
• Decision Date: 1984-03-19