510(k) K171441
K171441 is an FDA 510(k) premarket notification submitted by Luminex Corporation for the device "ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit". The FDA issued a decision of Substantially Equivalent on July 21, 2017. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Luminex Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2017
- Date Received
- May 16, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- C. Difficile Toxin Gene Amplification Assay
- Device Class
- Class II
- Regulation Number
- 866.3130
- Review Panel
- MI
- Submission Type
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.