ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY— 510(k) K132750
Substantially EquivalentIllumina, Inc.
FDA 510(k) clearance K132750 for ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY, Substantially Equivalent on 2013-11-19. Applicant: Illumina, Inc.. Device class: 2.
Clearance details
- Applicant
- Illumina, Inc.
- Product code
- Code PFS
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
More clearances from Illumina, Inc.
view allRecalls naming K132750
K-number listed on FDA's recall record- Z-0849-2015 — Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
- Z-0850-2015 — Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132750.
Data sourced from openFDA. This site is unofficial and independent of the FDA.