PYLORISET

Helicobacter Pylori

ORION DIAGNOSTICA, INC.

The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Pyloriset.

Pre-market Notification Details

• Device ID: K904655
• 510k Number: K904655
• Device Name: PYLORISET
• Classification: Helicobacter Pylori
• Applicant: ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI
• Contact: Timo Raines
• Correspondent: Timo Raines; ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI
• Product Code: LYR
• CFR Regulation Number: 866.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-10-12
• Decision Date: 1991-10-21