ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

C. Difficile Nucleic Acid Amplification Test Assay

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene C. Difficile, Illumipro-10 And Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920.

Pre-market Notification Details

• Device ID: K100818
• 510k Number: K100818
• Device Name: ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
• Classification: C. Difficile Nucleic Acid Amplification Test Assay
• Applicant: MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244
• Contact: Michelle L Smith
• Correspondent: Michelle L Smith; MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244
• Product Code: OMN
• CFR Regulation Number: 866.2660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-23
• Decision Date: 2010-07-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840733101663	K100818	000