AUTOLOADER

Station, Pipetting And Diluting, For Clinical Use

INNOVATIVE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Autoloader.

Pre-market Notification Details

• Device ID: K921005
• 510k Number: K921005
• Device Name: AUTOLOADER
• Classification: Station, Pipetting And Diluting, For Clinical Use
• Applicant: INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974
• Contact: Richard Crymes
• Correspondent: Richard Crymes; INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974
• Product Code: JQW
• CFR Regulation Number: 862.2750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-03
• Decision Date: 1992-04-29