TAG-IT CYSTIC FIBROSIS KIT

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

TM BIOSCIENCE CORPORATION

The following data is part of a premarket notification filed by Tm Bioscience Corporation with the FDA for Tag-it Cystic Fibrosis Kit.

Pre-market Notification Details

• Device ID: K060627
• 510k Number: K060627
• Device Name: TAG-IT CYSTIC FIBROSIS KIT
• Classification: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
• Applicant: TM BIOSCIENCE CORPORATION 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8
• Contact: Nancy Krunic
• Correspondent: Nancy Krunic; TM BIOSCIENCE CORPORATION 439 UNIVERSITY AVE. Toronto, Ontario, CA M5g 1y8
• Product Code: NUA
• CFR Regulation Number: 866.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-09
• Decision Date: 2006-06-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840487100455	K060627	000