GENESIS

Station, Pipetting And Diluting, For Clinical Use

TECAN U.S., INC.

The following data is part of a premarket notification filed by Tecan U.s., Inc. with the FDA for Genesis.

Pre-market Notification Details

• Device ID: K953345
• 510k Number: K953345
• Device Name: GENESIS
• Classification: Station, Pipetting And Diluting, For Clinical Use
• Applicant: TECAN U.S., INC. P.O. BOX 13953 Research Triangle Park, NC 27709
• Contact: David L Juranas
• Correspondent: David L Juranas; TECAN U.S., INC. P.O. BOX 13953 Research Triangle Park, NC 27709
• Product Code: JQW
• CFR Regulation Number: 862.2750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-12
• Decision Date: 1995-11-21