STREPTOCOCCUS APP. SEROLOGICAL REAGENTS

Group A Streptococcus Nucleic Acid Amplification Assay System

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Streptococcus App. Serological Reagents.

Pre-market Notification Details

• Device ID: K122019
• 510k Number: K122019
• Device Name: STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
• Classification: Group A Streptococcus Nucleic Acid Amplification Assay System
• 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: OYZ
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-10
• Decision Date: 2012-09-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840733102264	K122019	000
00840733102127	K122019	000
00840733101335	K122019	000
00840733101328	K122019	000