510(k) K212427
K212427 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas Cdiff nucleic acid test for use on the cobas Liat System". The FDA issued a decision of Substantially Equivalent on October 20, 2021. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2021
- Date Received
- August 4, 2021
- Clearance Type
- Special
- 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.