ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

ILLUMINA, INC.

The following data is part of a premarket notification filed by Illumina, Inc. with the FDA for Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay.

Pre-market Notification Details

• Device ID: K132750
• 510k Number: K132750
• Device Name: ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
• Classification: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
• Applicant: ILLUMINA, INC. 5200 ILLUMINA WAY San Diego, CA 92122
• Contact: Bryan Schneider
• Correspondent: Bryan Schneider; ILLUMINA, INC. 5200 ILLUMINA WAY San Diego, CA 92122
• Product Code: PFS
• CFR Regulation Number: 866.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-03
• Decision Date: 2013-11-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816270020026	K132750	000
00816270020385	K132750	000
00816270020262	K132750	000